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

Model Number	20E
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was able to verify and duplicate the reported issue.The user interface pcba was replaced to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the device logged a critical event that is associated with a device lock up and was intermittently booting up to a white display.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it was needed.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the device logged a critical event that is associated with a device lock up and was intermittently booting up to a white display.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it was needed.
Additional Manufacturer Narrative
Stryker further evaluated the device and determined the root cause was corrupt memory on integrated circuit, designator u2.

• 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: 15452096
• Report Number: 0003015876-2022-02095
• Device Sequence Number: 20557225
• Product Code: MKJ
• UDI-Device Identifier: 00885074515281
• UDI-Public: 00883873813805
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2011
• 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