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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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the device would not charge or discharge shock. Physical damage to the device's case was observed. Physio will replace the device's user interface board to resolve the issue. After observing proper device operation through functional and performance testing, the device will be returned to the customer for use.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device. There was no report of patient use associated with the reported event. During testing by physio-control, the device would not charge or deliver shock.
 
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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 Key11168688
MDR Text Key226770807
Report Number0003015876-2021-00112
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873813805
UDI-Public00883873813805
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20E
Device Catalogue Number99507-000010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2011
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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