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

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker further evaluated the customer¿s device, was able to duplicate the reported issue and determined that the cause of the reported issue was due to the incompatibility of the power control board.Due to a part obsolescence, the device cannot be repaired at this time.The customer will be provided with a replacement device.
Event or Problem Description
A customer contacted stryker to report that their device would not complete the boot-up cycle during the initial power-on.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Additonal manufacturer narrative: the device was returned to the customer unrepaired.Corrected data: section h11, additional mfg narrative on of the initial medwatch report indicates: "stryker further evaluated the customer¿s device, was able to duplicate the reported issue and determined that the cause of the reported issue was due to the incompatibility of the power control board.Due to a part obsolescence, the device cannot be repaired at this time." section h11, additional mfg narrative on of the initial medwatch report should indicate: "stryker further evaluated the customer¿s device, was able to duplicate the reported issue and determined that the cause of the reported issue was the power pcba.Due to a part obsolescence, the device cannot be repaired at this time.".
Event or Problem Description
A customer contacted stryker to report that their device would not complete the boot-up cycle during the initial power-on.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The power pcb assembly was returned to stryker product analysis center (pac) for further investigation.The pac technician was not able to duplcate the reported issue with the removed power pcb assembly.Therefore, the root cause of the reported issue could not be conclusively determined.
Event or Problem Description
A customer contacted stryker to report that their device would not complete the boot-up cycle during the initial power-on.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 18234889
• Report Number: 0003015876-2023-02245
• Device Sequence Number: 3226045
• Product Code: MKJ
• UDI-Device Identifier: 00883873988022
• UDI-Public: 00883873988022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/22/2024

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: 15
• Device Catalogue Number: 99577-000046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 10/16/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/23/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2011
• 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