Hidden failures questionnaire

From HTMcommunityDB.org

2.1 - Does the manufacturer's recommended PM procedure for this device (or the corresponding HTMC generic PM procedure) include one or more device performance verification or safety verification tasks?

Response: yes or no

2.2 - If yes, is it reasonably possible that there could be some kind of adverse patient outcome if one or more of those tests showed that the device is no longer meeting the relevant performance or safety specification?

Response: yes or no

2.3 - If yes, briefly describe the nature of the potentially adverse patient outcome

Response: Enter this scenario in column 5 of Table 3.

2.4 - Identify any possible mitigating factors that might reduce the severity of the expected outcome.

Response: Enter this information in column 7 of Table 3.

2.5 - After considering the possible mitigating factors listed in response to question 2.4 above, project the worst-case Level of Severity (LOS) of the outcome of the failure and enter in in column 6 of Table 3.

Response: LOS 0, LOS 1, LOS 2, or LOS 3

2.6 - What is the likelihood (projected or demonstrated) that this type of device will experience this type of hidden 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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