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	Device Inoperable (1663)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.It was also observed that one side of the power button was difficult to activate.Physio replaced the device's main keypad assembly.The battery pins were also replaced as a preventative measure.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that intermittently their device would have a blank display and the service indicator would be illuminated.In this state defibrillation therapy may not be available to a patient if needed.There was no patient use reported for this event.Upon evaluation of the customer¿s device, physio-control observed that the device was unable to complete a boot cycle and had a blank display.

• 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: 7661152
• Report Number: 0003015876-2018-01048
• Device Sequence Number: 1979509
• Product Code: MKJ
• UDI-Device Identifier: 00883873988053
• UDI-Public: 00883873988053
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 07/03/2018

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: 99577-000043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1