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 Patient Involvement (2645)
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Event Date 09/29/2014 |
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 from a quik-combo therapy cable had broken off and become lodged into their device's therapy connector assembly.As a result, defibrillation therapy may not be possible.There was no patient use associated with the reported event.
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Manufacturer Narrative
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(b)(4).Physio-control provided the customer, a biomedical engineer, with technical assistance.The customer purchased a replacement therapy connector assembly to resolve the reported issue.After replacing the therapy connector assembly and observing proper device operation through functional and performance testing, the unit will be placed back into service for use.
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Search Alerts/Recalls
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