Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 07/31/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device was not returned to physio-control.A third-party service agent performed an initial evaluation of the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Device not evaluated by manufacturer.
|
|
Event Description
|
A third-party service agent contacted physio-control to report that their customer's device had failed its daily user test.Upon initial evaluation, by the service agent, it was observed that the device had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
|
|
Manufacturer Narrative
|
The third-party service agent replaced the therapy pcb assembly and proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.The replaced therapy pcb assembly was further evaluated by physio-control failure analysis center and determined that the cause of the reported issue was due to shorted pins 5 to 9 on diode, designator cr30.
|
|
Event Description
|
A third-party service agent contacted physio-control to report that their customer's device had failed its daily user test.Upon initial evaluation, by the service agent, it was observed that the device had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
|
|
Search Alerts/Recalls
|