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 Patient Involvement (2645)
Date of Event	11/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control 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 physio-control to report that their device it locked up and the service indicator was illuminated.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.
Event or Problem Description
The customer contacted physio-control to report that their device it locked up and the service indicator was illuminated.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
Physio-control further evaluated the system pcb assembly from the customer's device and determined that the cause of the reported issue was due to the single board computer (sbc) on the system pcb assembly.The device was scrapped and the customer was sent a replacement device.
Additional Manufacturer Narrative
The device was returned for evaluation therefore, section d10 has been updated accordingly with the new information.Physio-control evaluated the customer¿s device and determined that the cause of the reported issue was due to the system pcb assembly.Due to a part obsolescence, the device cannot be repaired at this time.The customer has received a loaner unit until a permanent solution is identified.
Event or Problem Description
The customer contacted physio-control to report that their device it locked up and the service indicator was illuminated.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
• MDR Report Key: 9371944
• Report Number: 0003015876-2019-01892
• Device Sequence Number: 11311991
• Product Code: MKJ
• UDI-Device Identifier: 00883873979419
• UDI-Public: 00883873979419
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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: 99577-000056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/03/2019
• Supplement Date Received by Manufacturer: 01/31/2020; 06/16/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/03/2020; 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1