MAUDE Adverse Event Report: Physio-Control, Inc. - 3015876 LIFEPAK 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	08/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device but was unable to duplicate the reported issue.Customer declined further evaluation since the device is obsolete and removed the device from service.The root cause was not established.Stryker contacted the customer to request additional information on the patient.Stryker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.
Event or Problem Description
The customer contacted stryker to report that their device would not charge during a patient case.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• Brand Name: LIFEPAK 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: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 50756462
• Report Number: 0003015876-2026-01847
• Device Sequence Number: 15763251
• Product Code: MKJ
• UDI-Device Identifier: 00883873912805
• UDI-Public: 00883873912805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/14/2026

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: 99577-001216
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2011
• 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