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

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was able to verify the reported issue was logged in the device¿s memory.The device's battery pins were replaced as a precaution.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Stryker requested additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.Stryker was informed that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
A customer contacted stryker to report that their device froze.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient use associated to the reported event.
Event or Problem Description
A customer contacted stryker to report that their device froze.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Section h11 of initial medwatch report indicates: stryker evaluated the customer's device and was able to verify the reported issue was logged in the device¿s memory.Section h11 of initial medwatch report should indicate: stryker evaluated the customer's device and was not able to be verify or duplicate the reported issue.Section h6 of initial medwatch report indicates: operational problem identified.Section h6 of initial medwatch report should indicate: no device problem found.Root cause was not established.

• 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: 22382321
• Report Number: 0003015876-2025-01336
• Device Sequence Number: 9355049
• Product Code: MKJ
• UDI-Device Identifier: 00883873814185
• UDI-Public: 00883873814185
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 99577-000006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2009
• 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