Model Number 1000 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Physio control evaluated the customer's device and verified the reported issue.Physio control replaced the customer's device under the warranty.The reported device will be sent for the further evaluation to our failure analysis center.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.
|
|
Event Description
|
The customer contacted physio control to report that their would deliver monophasic shocks.In this state there will be a partial loss of defibrillator output energy due to a loss of a 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 report of patient use associated with the reported event.
|
|
Manufacturer Narrative
|
The customer's device was further evaluated in the product analysis center (pac).It was observed that the device analog pcb component - integrated circuit, u1 had legs 1 and 16 lifted.The root cause of the reported issue of the device therapy output being a monophasic waveform instead of bi-phasic was due to the damage caused to the u1 h-bridge component.The device was destructively tested.
|
|
Event Description
|
The customer contacted physio control to report that their would deliver monophasic shocks.In this state there will be a partial loss of defibrillator output energy due to a loss of a 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 report of patient use associated with the reported event.
|
|
Search Alerts/Recalls
|