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

Model Number	15
Medical Device Problem Code	Pacing Inadequately (1442)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker received additional patient information from the customer.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.A clinical review will be performed to determine actual device contribution.Stryker continues to investigate the reported failure 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 while pacing a patient the pacer lost capture.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Stryker performed a clinical review regarding the reported issue.Reviewed of the patient's electronic data reveal that the device use may have contributed to the patient's outcome.
Event or Problem Description
The customer contacted stryker to report that their device while pacing a patient the pacer lost capture.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device while pacing a patient the pacer lost capture.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Stryker performed an additional clinical review of the reported event.It was determined that the device use did not contribute to the patient's outcome as there is evidence of user error in the electronic event data downloaded from the device.
Event or Problem Description
The customer contacted stryker to report that their device while pacing a patient the pacer lost capture.The patient associated with the reported event did not survive.

• 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: 19524813
• Report Number: 0003015876-2024-01887
• Device Sequence Number: 8337475
• Product Code: MKJ
• UDI-Device Identifier: 00883873871676
• UDI-Public: 00883873871676
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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,Followup,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 10/29/2024; 05/08/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/23/2024; 11/27/2024; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White