PHYSIO-CONTROL, INC LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; DEFIBRILLATORS, AUTOMATIC, EXTERNAL
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Catalog Number VLP12-02B |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/11/2014 |
Event Type
malfunction
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Event Description
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The customer, a biomedical engineer, contacted physio-control to report that a pin had broken off of a quik-combo therapy cable assembly and become lodged into their device's therapy connector assembly.This issue was discovered during patient use, however no further details about the event were provided and no adverse effects to the patient were reported as a result of the reported issue.
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Manufacturer Narrative
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(b)(4).Physio-control provided the customer with troubleshooting assistance, as well as assisted the customer with ordering a new quik-combo therapy cable assembly and replacement therapy connector assembly needed in order to complete the repair.Once the repair has been completed, and after observing proper device operation through functional and performance testing, the device will be placed back into service for use.Neither the device, nor the quik-combo therapy cable assembly were returned to physio for evaluation.
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