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Wear-out failures questionnaire

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1.1 - Does the manufacturer's recommended PM procedure for this device (or the corresponding HTMC generic PM procedure) include one or more device restoration tasks?
Response: yes or no
1.2 - If yes, is it reasonably possible that the device will stop working properly if one (or more) of these device restoration tasks is not completed in a competent and timely manner?
Response: yes or no
1.3 - If yes, is it reasonably possible that there could be some kind of adverse patient outcome if this device, without reasonable warning, stops working while being used on a patient?
Response: yes or no
1.4 - If yes, briefly describe the nature of the potentially adverse patient outcome
Response: Enter this scenario in column 6 of Table 2.
1.5 - Identify any possible mitigating factors that might reduce the severity of the expected outcome.
Response: Enter this information in column 8 of Table 2.
1.6 - After considering the possible mitigating factors listed in response to question 1.5 above, project the worst-case Level of Severity (LOS) of the outcome of the failure and enter in in column 7 of Table 2.
Response: LOS 0, LOS 1, LOS 2, or LOS 3
1.7 - What is the likelihood (projected or demonstrated) that this type of device will experience this type of wear-out failure?
Response: Quite likely; Not very likely; Very unlikely; Unknown. If the likelihood is unknown, the resulting classification should be considered "worst case potential risk"
In Phase 2 of the MPTF project the "likelihood" information will enable final resolution of the device's PM risk category which will then be entered into the appropriate section of Table 5.

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