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

Model Number	15
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report an observed event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.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
The device was not returned to stryker for evaluation.The customer shipped the device to stryker for evaluation/repair; however, it was lost in transit before its arrival.A replacement was provided to the customer to resolve the issue.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report an observed event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report an observed event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker was able to track down the device that previously thought was lost in transit.Stryker evaluated the customer's device and was able to verify the reported issue.Stryker determined the issue was due to the therapy pcba.Stryker further evaluated the removed therapy pcb assembly.It was observed that the transistor, designator q8, was electrically shorted.Stryker archived the device and the customer received a replacement.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16793139
• Report Number: 0003015876-2023-00726
• Device Sequence Number: 12484948
• Product Code: MKJ
• UDI-Device Identifier: 00883873871805
• UDI-Public: 00883873871805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/09/2023

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: 99577-001946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 09/27/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/12/2023; 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2016
• 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