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	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device but was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing the device was returned to the customer for use.The cause of the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted physio-control to report that their device froze when delivering a shock during testing.The customer advised that when the shock button was pressed, the device froze for 15 seconds and did not indicate the shock was delivered.However the test equipment did state the shock was delivered.The device was powered off and then on, thereafter proper device operation was observed.In this state defibrillation therapy may be delayed or not available to a patient if needed.There was no patient use associated with this 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: 8761381
• Report Number: 0003015876-2019-01156
• Device Sequence Number: 19451130
• Product Code: MKJ
• UDI-Device Identifier: 00883873871638
• UDI-Public: 00883873871638
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 07/03/2019

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: 99577-001963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1