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	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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, a biomedical engineer contacted physio-control to report that their device was unable to power on.The customer advised that the batteries in the device were checked and were found to be good.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control provided the customer with technical assistance.Physio has made multiple attempts to contact the customer regarding the status of their devices but has not been successful.It is unknown if the customer will be replacing the devices or returning them to physio-control for evaluation.The devices have not been returned to physio-control.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer, a biomedical engineer contacted physio-control to report that their device was unable to power on.The customer advised that the batteries in the device were checked and were found to be good.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: 7907731
• Report Number: 0003015876-2018-01586
• Device Sequence Number: 1654441
• Product Code: MKJ
• UDI-Device Identifier: 00883873988077
• UDI-Public: 00883873988077
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/07/2018

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: 99577-000041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1