(b)(4).The customer, a biomedical engineer, verified the reported issue.At the customer¿s request, physio-control provided the biomedical engineer with the part numbers for a replacement therapy connector assembly and hard paddles assembly, so that the necessary repairs could be completed.Neither the device nor the broken hard paddles were returned to physio-control for evaluation.Device not evaluated by manufacturer.
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The customer, a biomedical engineer, contacted physio-control to report that a connector pin from the device¿s hard paddles assembly had broken off and become lodged in their device¿s therapy connector.As a result, defibrillation may not be possible if it were necessary.There was no patient use associated with the reported event.
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