The customer, a biomedical engineer, contacted physio-control to report that during a daily check of their device, they observed that a pin had broken off of a hard paddles assembly and become lodged in their device's therapy connector assembly.As a result, another set of hard paddles, or a quik-combo cable could not be installed and the device would not be able to provide defibrillation therapy, if it were necessary.There was no patient use associated with the reported event.
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(b)(4).The biomedical engineer advised that he was able to remove the broken pin from the device's therapy connector assembly which resolved the reported issue.The hard paddles with the broken pin were disposed of and a replacement set was obtained.After observing proper device operation through functional and performance testing the unit was placed back into service for use.Neither the device, nor the hard paddles assembly with the broken pin, have been returned to physio-control for evaluation.
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