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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.
 
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Brand NameLIFEPAK 20E DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key12558875
MDR Text Key274254823
Report Number0003015876-2021-01884
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were 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
Device Model Number20E
Device Catalogue Number99507-000093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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