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

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.It was determined that the system pcb assembly needed replacement.Failure of the system pcb assembly was likely the cause of the reported issue however it could not be confirmed.Due to device age, the parts were not available and so device could not be repaired but was scrapped.
Event or Problem Description
The customer contacted physio-control to report that their device locks up at self test in progress with service lights on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Upon further evaluation by physio-control it was determined that the root cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device locks up at self test in progress with service lights on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.

• 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
• MDR Report Key: 10522524
• Report Number: 0003015876-2020-01238
• Device Sequence Number: 3438362
• Product Code: MKJ
• UDI-Device Identifier: 00883873979358
• UDI-Public: 00883873979358
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 11/06/2020

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: 99577-000061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1