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

Model Number	15
Medical Device Problem Codes	Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device powered off by itself multiple times during a patient event.Thereafter, the device would no longer power on.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome.
Additional Manufacturer Narrative
Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided available patient information.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report that their device powered off by itself multiple times during a patient event.Thereafter, the device would no longer power on.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device but was unable to duplicate the reported issue.Stryker downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced an inappropriate loss of power.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Based on the electronic records from the device, the unexpected loss of power is likely due to a failure of the ac power adapter accessory.However, a conclusive cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 20380009
• Report Number: 0003015876-2024-02815
• Device Sequence Number: 21226046
• Product Code: MKJ
• UDI-Device Identifier: 00883873912782
• UDI-Public: 00883873912782
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/20/2025

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: 99577-001218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/06/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2013
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: Black Or African American