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

Model Number	15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the customer with technical assistance and a quote for repair.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device would not complete a boot cycle.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 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 would not complete a boot cycle.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: 8751043
• Report Number: 0003015876-2019-01131
• Device Sequence Number: 1998975
• Product Code: MKJ
• UDI-Device Identifier: 00883873979105
• UDI-Public: 00883873979105
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 99577-000085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1