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

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device will not deliver defibrillation energy through the paddles.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Corrected data: section h5, labeled for single use of the initial medwatch report indicates: yes section h5, labeled for single use of the initial medwatch report should indicate: no.Additional manufacturer narrative: stryker evaluated the customer's device and was unable to duplicate the reported issue.After replacing the main keypad and the battery pins as a precautionary measure, proper device operation was observed through functional and performance testing and the device was, subsequently, returned to the customer for use.The device's electronic files were reviewed by a stryker customer quality engineer and the reported issue could not be verified.Instances were observed in the device logs of the charge being disarmed/removed due to the speed dial being pressed; however the inability to deliver energy through the paddles could not be duplicated.Therefore, a conclusive root cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device will not deliver defibrillation energy through the paddles.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.

• 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: 19645672
• Report Number: 0003015876-2024-02046
• Device Sequence Number: 12408962
• Product Code: MKJ
• UDI-Device Identifier: 00883873871768
• UDI-Public: 00883873871768
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/07/2024

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: 99577-001950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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
• Patient Sex: Unknown