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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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Brand Name
LIFEPAK(R) 1000 DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9513727
MDR Text Key190672174
Report Number0003015876-2019-02062
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1000
Device Catalogue Number99425-000104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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