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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker evaluated the customer's device and duplicated the reported issue.Stryker determined a faulty system pcb was the cause of the reported issue.Due to part obsolescence, the device cannot be repaired.Stryker recommended the customer remove the device from service and a replacement device be obtained.
Event or Problem Description
The customer contacted stryker to report that their device shut off during use.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse event reported.
Event or Problem Description
The customer contacted stryker to report that their device shut off during use.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse event reported.
Additional Manufacturer Narrative
Section h11 of the initial medwatch report indicates: stryker evaluated the customer's device and duplicated the reported issue.Stryker determined a faulty system pcb was the cause of the reported issue.Due to part obsolescence, the device cannot be repaired.Stryker recommended the customer remove the device from service and a replacement device be obtained.Section h11 of the initial medwatch report should indicate: stryker evaluated the customer's device and duplicated the reported issue.Stryker determined the most likely cause is a faulty system pcb.Due to part obsolescence, the device cannot be repaired.Stryker recommended the customer remove the device from service and a replacement device be obtained.A conclusive root cause could not be determined.

• 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: 21468946
• Report Number: 0003015876-2025-00366
• Device Sequence Number: 11657651
• Product Code: MKJ
• UDI-Device Identifier: 00883873911723
• UDI-Public: 00883873911723
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/30/2025

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: 99577-001247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2013
• 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