PHYSIO-CONTROL, INC LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; DEFIBRILLATORS, AUTOMATIC, EXTERNAL
|
Back to Search Results |
|
Catalog Number VLP12-02B |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 05/14/2015 |
Event Type
malfunction
|
Event Description
|
The customer, a biomedical engineer, contacted physio-control to report that a pin had broken off of a therapy cable assembly become lodged in their device's therapy connector assembly.As a result, the device would not detect that the therapy cable was connected and defibrillation was not possible.There was no patient use associated with the reported event.
|
|
Manufacturer Narrative
|
(b)(4).Physio-control provided the customer, a biomedical engineer, with technical assistance.It was later confirmed by the biomedical engineer that the therapy connector assembly was replaced to resolve the reported issue.Additionally, the damaged therapy cable assembly was disposed of and a replacement cable 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 damaged therapy cable assembly have been returned to physio-control for evaluation.
|
|
Search Alerts/Recalls
|
|
|