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	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that the defibrillation energy charge on their device was inoperative.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
A stryker field service representative evaluated the customer's device and was able to verify the reported issue.The stryker fsr found a melted cable connector on the capacitor discharge pcb.The stryker fsr replaced the device's capacitor discharge pcb assembly, the wire harness therapy capacitor and the energy storage capacitor to resolve the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
Additional Manufacturer Narrative
Corrected data: section h11: additional mfg narrative of the initial medwatch report indicates: a stryker field service representative evaluated the customer's device and was able to verify the reported issue.The stryker fsr found a melted cable connector on the capacitor discharge pcb.The stryker fsr replaced the device's capacitor discharge pcb assembly, the wire harness therapy capacitor and the energy storage capacitor to resolve the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Section h11: additional mfg narrative of the initial medwatch report should indicate: a stryker field service representative evaluated the customer's device and was able to verify the reported issue.The stryker fsr found a melted cable connector on the capacitor discharge pcb.The stryker fsr replaced the device's capacitor discharge pcb assembly, the wire harness therapy capacitor, the energy storage capacitor and the therapy pcb assembly to resolve the reported issues.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Additional manufacturer narrative: the root cause of the reported issue was determined to be failed/faulty components on the therapy pcb assembly.
Event or Problem Description
The customer contacted stryker to report that the defibrillation energy charge on their device was inoperative.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient involvement reported with the 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: 18730370
• Report Number: 0003015876-2024-00360
• Device Sequence Number: 8275982
• Product Code: MKJ
• UDI-Device Identifier: 00883873871706
• UDI-Public: 00883873871706
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 99577-001956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2018
• 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