Device Deficiencies Sample Clauses

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Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with patient harm (ie, ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The Investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately.
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Device Deficiencies. Safety Assessment
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Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with subject harm (ie, ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The Investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any subject harm separately. Examples of device deficiencies include the following: • Failure to meet product specifications (eg, incorrect lens power/diameter/base curve/color) • Lens cloudy • Lens surface/edge defect • Torn lens during handling/in pack • Packaging deficit (eg, mislabeled product) • Suspect product contamination • Lack of performance
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Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately. Examples of device deficiencies include the following: • Failure to meet product specifications (e.g., incorrect lens power/diameter/base curve/color) • Lens/solution cloudy • Lens surface/edge defect • Torn lens during handling/in pack • Packaging deficit (e.g., mislabeled product, tampered seal, leaking bottle/container) • Suspect product contamination • Lack of performance
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Device Deficiencies. The VSA app is an NSR device, but since the device does not diagnose or provide therapy, no device deficiencies are anticipated. Software bugs within the VSA app, either found by the study team or reported by the participant will not be considered a device deficiency. If, at any time during the study, the participant’s Smartphone (where the VSA app is installed) physically breaks, or malfunctions, or the VSA app ceases to function or gives unexpected or erroneous information, participants will be instructed to stop using the VSA app and contact the study team. If the participant has another compatible Smartphone, instructions on installing the VSA app on a different Smartphone will be provided and the participants will be instructed on how to remove the VSA app on the first Smartphone (if applicable). If, at any time during the study, a commercially available (i.e., FDA cleared or approved) device (PAP and associated supplies) physically breaks, or malfunctions, or gives unexpected or erroneous information, participants will be instructed to contact their DME provider. The DME provider may provide a replacement device or repairs at the sponsor’s discretion. Alternatively, the sponsor may choose to exit the participant without providing a replacement device. The sponsor will not provide maintenance or support for any commercially available (i.e., FDA cleared or approved) devices (PAP and associated supplies). If a participant reports a device malfunction and/or device complaint to the sponsor support team (Verily User Success), the participant will be instructed to contact their DME provider. The sponsor support team may contact study participants during study participation in order to troubleshoot issues with the VSA app, such as issues logging in or the app crashing.
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Device Deficiencies. A device deficiency may or may not be associated with subject harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The investigator should determine the applicable category for the identified or suspect device deficiency and report any subject harm separately. • Event 1 • Event 2 • Event 3, etc.
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Device Deficiencies. Assess and record any device deficiencies that are reported or observed at each study visit, including those associated with changes in concomitant medication dosing since the previous visit. Requirements for reporting device deficiencies in the study can be found in Section 11. Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of signature of informed consent, regardless of subject enrollment status (screen failure or randomized). .
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Device Deficiencies. The number and percentage of all device deficiencies will be tabulated with a breakdown by treatment and implanted eye. A listing of all device deficiencies will also be provided. The number and percentage of all IOL observations will be tabulated with a breakdown by treatment and implanted eye. The number and percentage of eyes within each category of subjective posterior capsule opacification will be tabulated with a breakdown by treatment and implanted eye.
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Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately. Examples of device deficiencies include the following: • Len missing/folded/fragments/Lens cloudy/dirty • Lens surface/edge defect • Torn lens during handling/in pack • Packaging deficit (e.g., blister strip damage, primary/secondary label mismatch, mislabeled product, tampered seal) • Potential contaminant
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Related to Device Deficiencies

  • Performance Deficiencies If the City or the Quality Control Manager determine in their reasonable belief that any of the Infrastructure Improvements are not being constructed in accordance with the Infrastructure Improvement Plans or this Agreement in any material respect, they shall immediately notify RCP and Bliss Sports II in writing stating the alleged deficiency and the City, the Quality Control Manager, the Architect, RCP and Bliss Sports II will meet within seven (7) days of the giving of such notice to discuss whether the Infrastructure Improvements are not being constructed in accordance with the Infrastructure Improvement Plans or this Agreement in any material respect and, if the City, RCP and Architect agree that they are not, then RCP shall cause Bliss Sports II to correct such deficiencies. The failure by the City to provide any notice of any observed deficiency shall not give rise to any liability to the City and shall not be considered a waiver of any right of the City under this Agreement, including, without limitation, the enforcement of the representations and warranties of Bliss Sports II under this Agreement and any warranties that may be made to the City by any Contracting Parties under the Infrastructure Construction Contract Documents with respect to the completion of the Infrastructure Improvements in accordance with the Infrastructure Improvement Plans and the Project Timeline.

  • Elements Unsatisfactory Needs Improvement Proficient Exemplary IV-A-1. Reflective Practice Demonstrates limited reflection on practice and/or use of insights gained to improve practice. May reflect on the effectiveness of lessons/ units and interactions with students but not with colleagues and/or rarely uses insights to improve practice. Regularly reflects on the effectiveness of lessons, units, and interactions with students, both individually and with colleagues, and uses insights gained to improve practice and student learning. Regularly reflects on the effectiveness of lessons, units, and interactions with students, both individually and with colleagues; and uses and shares with colleagues, insights gained to improve practice and student learning. Is able to model this element.

  • Borrowing Base Deficiency (i) Other than as provided in clause (ii) below, if the aggregate outstanding amount of the Advances plus the Letter of Credit Exposure ever exceeds the lesser of the (y) Borrowing Base and (z) the aggregate Commitments, the Borrower shall, after receipt of written notice from the Administrative Agent regarding such deficiency, take any of the following actions (and the failure of the Borrower to take such actions to remedy such Borrowing Base deficiency shall constitute an Event of Default): (A) prepay Advances or, if the Advances have been repaid in full, make deposits into the Cash Collateral Account to provide cash collateral for the Letter of Credit Exposure, such that the Borrowing Base deficiency is cured within 10 Business Days after the date such deficiency notice is received by the Borrower from the Administrative Agent; (B) pledge as Collateral for the Obligations additional Oil and Gas Properties acceptable to the Administrative Agent and each of Lenders such that the Borrowing Base deficiency is cured within 30 days after the date such deficiency notice is received by the Borrower from the Administrative Agent; (C) (i) deliver, within 10 Business Days after the date such deficiency notice is received by the Borrower from the Administrative Agent, written notice to the Administrative Agent indicating the Borrower’s election to repay the Advances and make deposits into the Cash Collateral Account to provide cash collateral for the Letters of Credit, each in five monthly installments equal to one-fifth of such Borrowing Base deficiency with the first such installment due 30 days after the date such deficiency notice is received by the Borrower from the Administrative Agent and each following installment due 30 days after the preceding installment and (ii) make such payments and deposits within such time periods; provided that, the Borrowing Base deficiency cure permitted under this clause (C) shall not be available to the Borrower unless, concurrent with the written notice delivered to the Administrative Agent electing this option, the Borrower shall have delivered to the Administrative Agent a calculation of the Borrower’s consolidated cash flow forecast and financial projections which demonstrates, to the Administrative Agent’s satisfaction, the Borrower’s ability to make each such installment payments and to otherwise pay its other Debt and trade accounts payable as they become due; or (D) (i) deliver, within 10 Business Days after the date such deficiency notice is received by the Borrower from the Administrative Agent, written notice to the Administrative Agent indicating the Borrower’s election to combine the options provided in clause (B) and clause (C) above, and also indicating the amount to be prepaid in installments and the amount to be provided as additional Collateral, and (ii) make such five equal consecutive monthly installments and deliver such additional Collateral within the time required under clause (B) and clause (C) above. (ii) Upon each reduction of the Borrowing Base, if any, resulting from a Borrowing Base redetermination made under Section 2.02(c)(ii) or (iii), if the aggregate outstanding amount of the Advances plus the Letter of Credit Exposure exceeds the lesser of the (y) Borrowing Base and (z) the aggregate Commitments, then the Borrower shall immediately prepay the Advances or, if the Advances have been repaid in full, make deposits into the Cash Collateral Account to provide cash collateral for the Letter of Credit Exposure, in an amount equal to (A) such portion of the Borrowing Base deficiency resulting from such reduction plus (B) if a Borrowing Base deficiency exists prior to such reduction, then an amount equal to the lesser of (i) the net cash proceeds of the transaction that triggered such Borrowing Base reduction and (ii) such portion of the Borrowing Base deficiency in existence immediately prior to such reduction. (iii) Each prepayment pursuant to this Section 2.05(b) shall be accompanied by accrued interest on the amount prepaid to the date of such prepayment and amounts, if any, required to be paid pursuant to Section 2.12 as a result of such prepayment being made on such date. Each prepayment under this Section 2.05(b) shall be applied to the Advances as determined by the Administrative Agent and agreed to by the Lenders in their sole discretion. The failure of the Borrower to provide a notice of its election within the required 10 days as required in clause (i) above shall be deemed to be an election by the Borrower to take the actions provided in clause (i)(A) above.

  • Nonconforming Work 5.6.1 Rejection, Removal and Replacement of Nonconforming Work

  • Subprocessing The data importer shall not subcontract any of its processing operations performed on behalf of the data exporter under the Clauses without the prior written consent of the data exporter. Where the data importer subcontracts its obligations under the Clauses, with the consent of the data exporter, it shall do so only by way of a written agreement with the subprocessor which imposes the same obligations on the subprocessor as are imposed on the data importer under the Clauses. Where the subprocessor fails to fulfil its data protection obligations under such written agreement the data importer shall remain fully liable to the data exporter for the performance of the subprocessor's obligations under such agreement.