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

Model Number	15
Medical Device Problem Codes	Power Problem (3010); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device's display goes blank and the device loses power.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that their device's display goes blank and the device loses power.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was able to verify and duplicate the reported issue.Investigation determined the cause of the reported issue was a faulty accessory power supply.The device works as expected with a known working power supply.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The customer was advised to purchase a new power supply.The device was returned to the customer for use.Stryker determined that the likely cause of the reported issue was due to process adhesive on one of the device¿s ac input pcbs.This can trigger the overvoltage protection of the ac power adapter and may result in the device being unable to power on or charge the batteries.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18378906
• Report Number: 0003015876-2023-02454
• Device Sequence Number: 12714134
• Product Code: MKJ
• UDI-Device Identifier: 00883873871751
• UDI-Public: 00883873871751
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/21/2024

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: 99577-001951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• 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