MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20E
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker completed an initial evaluation of the customer's device and was unable to 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 or Problem Description
The customer contacted stryker to report that their device was not turning on with ac or dc power.In this state the device would be inoperable and defibrillation therapy may not be available if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the device did not function with ac alone and could not charge dc battery.Device powered on with a known good dc battery installed.Stryker replaced the device's power module to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing and the device returned to the customer for use.The ac portion of power module is not functioning (no ac only operation and no battery charging) was determined to be cause of the reported issue.
Event or Problem Description
The customer contacted stryker to report that their device was not turning on with ac or dc power.In this state the device would be inoperable and defibrillation therapy may not be available if needed.There was no patient involvement reported with the event.

• Brand Name: LIFEPAK® 20E DEFIBRILLATOR/MONITOR
• Common Device Name: 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 Key: 13978355
• Report Number: 0003015876-2022-00476
• Device Sequence Number: 17640999
• Product Code: MKJ
• UDI-Device Identifier: 00883873813751
• UDI-Public: 00883873813751
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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 Model Number: 20E
• Device Catalogue Number: 99507-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown