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	08/01/2018
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 contacted physio-control to report that intermittently their device would have a blank display.When this occurred the device buttons were unresponsive.In this state defibrillation therapy may not be available to a patient if needed.There was no patient use reported for this event.
Event or Problem Description
The customer contacted physio-control to report that intermittently their device would have a blank display.When this occurred the device buttons were unresponsive.In this state defibrillation therapy may not be available to a patient if needed.There was no patient use reported for this event.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device and was unable to duplicate the reported issue.The cause of the reported issued could not be conclusively determined.The customer was sent a replacement device.

• 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: 7799519
• Report Number: 0003015876-2018-01335
• Device Sequence Number: 11281725
• Product Code: MKJ
• UDI-Device Identifier: 00883873871645
• UDI-Public: 00883873871645
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 99577-001962
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1