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	Intermittent Loss of Power (4016); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 unexpectedly lost power.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that their device unexpectedly lost power.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative performed evaluation of the customer¿s device and was not able to duplicate the reported issue.A customer quality engineer evaluated the device electronic records and verified multiple instances of unexpected device shutdowns on 3/16/2024, the date of the reported event.Additionally, during the event, battery 1 was observed to have a manufacture date of 9/20/2021 and was at low power (5-10%).Frequent switching between battery 1 and 2 was also observed in between the shutdowns.Per the lifepak 15 operating instructions (oi), it is warned that a low battery warning and result possible device shutdown, and to replace the battery when the device displays a low battery warning.Additionally, the oi also recommends replacing the device batteries every two years to ensure adequate battery performance.However, a conclusive root cause was unable to be determined.The battery pins and batteries are replaced as a precautionary measure.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.

• 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: 19085900
• Report Number: 0003015876-2024-00739
• Device Sequence Number: 17917863
• Product Code: MKJ
• UDI-Device Identifier: 00883873871706
• UDI-Public: 00883873871706
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 07/25/2024

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: 99577-001956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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