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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE Back to Search Results
Model Number 20E
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
It was reported, lifepak 20e device, customer reported "the service light is on and the unit is stuck saying "self test in progress".In this state the device may be unable to power up and thus unable to perform defibrillation therapy if needed.There was no report of patient involvement associated with this event.
 
Event Description
It was reported, lifepak 20e device, customer reported "the service light is on and the unit is stuck saying "self test in progress".In this state the device may be unable to power up and thus unable to perform defibrillation therapy if needed.There was no report of patient involvement associated with this event.
 
Manufacturer Narrative
Physio-control evaluated the device and verified the issue; it displayed "self-test" and would not complete power up cycle.The cause was determined to be the system pcb.The system pcb was replaced and after other unrelated repairs, the device passed functional and performance testing and was returned to the customer for use.
 
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Brand Name
LIFEPAK 20E DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key12558875
MDR Text Key274254823
Report Number0003015876-2021-01884
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873887790
UDI-Public00883873887790
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Date Manufacturer Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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