PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL
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Model Number 20 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/23/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio-control provided the customer, a biomedical engineer, with technical assistance.It was later confirmed by the customer that he replaced the device's therapy connector assembly, as well as the damaged quik-combo therapy cable.After observing proper device operation through functional and performance testing the unit will be placed back into service for use.The device has not been returned to physio-control for evaluation.
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Event Description
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The customer, a biomedical engineer, contacted physio-control to report that a couple of pins from a quik-combo therapy cable had broken off and become lodged in their device's therapy connector assembly.As a result, defibrillation may not be possible.There was no patient use associated with the reported event.
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