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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 12/28/2021
Event Type  malfunction  
Manufacturer Narrative
Stryker performed an initial evaluation on the customer's device and could not duplicate the reported issue.Stryker 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
The customer contacted stryker to report that their device would unexpectedly dump the defibrillation charge.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
 
Event Description
The customer contacted stryker to report that their device would unexpectedly dump the defibrillation charge.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
 
Manufacturer Narrative
Stryker further evaluated the device and the reported issue was unable to be verified and unable to be duplicated.Root cause is unable to be determined.Repairs unrelated to the reported issue were complete.The device passed functional and performance testing and was returned to the customer.
 
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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
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 Key13266589
MDR Text Key284540504
Report Number0003015876-2022-00061
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873813768
UDI-Public00883873813768
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160026
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Initial Date Manufacturer Received 12/28/2021
Initial Date FDA Received01/17/2022
Supplement Dates Manufacturer Received03/28/2022
Supplement Dates FDA Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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