MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 35 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	35
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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.A stryker field service technician evaluated the customer's device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
Event or Problem Description
A customer contacted stryker to report that their device had powered off during patient use.As a result, defibrillation therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
Event or Problem Description
A customer contacted stryker to report that their device had powered off during patient use.As a result, defibrillation therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
Additional Manufacturer Narrative
The device logs were reviewed and the reported issue was verified.The root cause of the reported issue was determined to be due to the device software.

• Brand Name: LIFEPAK 35 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: 23923812
• Report Number: 0003015876-2025-02760
• Device Sequence Number: 9013749
• Product Code: MKJ
• UDI-Device Identifier: 00883873765609
• UDI-Public: 00883873765609
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/12/2026

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: 35
• Device Catalogue Number: 99335-000031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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