MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
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 cause of the reported issue was isolated to the therapy pcb and replaced to resolve the issue.The device passed functional and performance testing and was returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report that their device's service indicator is present, and an event code is logged in the device's memory.The event code logged in the device's memory can indicate that the aed function of the device may be inoperable.As a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode if it was necessary.There was no patient involvement reported during the event.
Event or Problem Description
The customer contacted stryker to report that their device's service indicator is present, and an event code is logged in the device's memory.The event code logged in the device's memory can indicate that the aed function of the device may be inoperable.As a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode if it was necessary.There was no patient involvement reported during the event.
Additional Manufacturer Narrative
Stryker further evaluated the removed therapy pcb assembly.It was observed that the capacitor, designator c160 was leaking voltage.

• Brand Name: LIFEPAK® 15 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17123730
• Report Number: 0003015876-2023-01079
• Device Sequence Number: 20445219
• Product Code: MKJ
• UDI-Device Identifier: 00883873911709
• UDI-Public: 00883873911709
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 06/20/2023

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: 15
• Device Catalogue Number: 99577-001249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2014
• 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