MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 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	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker service representative performed an evaluation of the customer¿s device and observed that the device was logging random key events that were not actually happening.Stryker continues to investigate the reported issue 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 a non-critical issue with their device.During evaluation stryker observed that the device was logging random key events that were not actually happening.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify but not able to duplicate the reported issue.Stryker further evaluated the device at the product assessment center (pac) and was not able to duplicate the reported issue.The user interface pcb assembly was replaced to solve the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A root cause of the reported issue could not be determined.Section b5 executive summary of initial mdr indicates: the customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the device was logging random key events that were not actually happening.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the device was logging random key events (buttons presses) by itself.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18666091
• Report Number: 0003015876-2024-00292
• Device Sequence Number: 15235897
• Product Code: MKJ
• UDI-Device Identifier: 00883873887707
• UDI-Public: 00883873887707
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/25/2024

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: 99507-000102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2015
• 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