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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device would not complete a boot cycle.The customer advised that the device would freeze on the start up screen.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer¿s device and verified the reported issue.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 would not complete a boot cycle.The customer advised that the device would freeze on the start up screen.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker determined that due to the device model, repair was not feasible.As a result, the customer opted to order and receive a replacement device.The likely cause of the issue can be attributed to the system pcba.The device was returned unrepaired to the customer.
Additional Manufacturer Narrative
The customer received a replacement device.The system pcb assembly from the customer's original device was removed for further evaluation and the device scrapped by stryker.Stryker further evaluated the removed system pcb assembly.Stryker determined that the cause of the reported issue was due to the single board computer (sbc).The sbc was corrupt and no longer functioning.
Event or Problem Description
The customer contacted stryker to report that their device would not complete a boot cycle.The customer advised that the device would freeze on the start up screen.In this state the device would be inoperable and defibrillation therapy would not be available 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17116583
• Report Number: 0003015876-2023-01066
• Device Sequence Number: 15096618
• Product Code: MKJ
• UDI-Device Identifier: 00883873988022
• UDI-Public: 00883873988022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/21/2023

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: 99577-000046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 12/20/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/28/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2011
• 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