MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99400-002505
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and was unable to duplicate the reported issue.Physio observed the main keypad assembly to be worn and was replaced as a precaution.Thereafter proper device operation was observed through functional and performance testing and the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself during a patient event.The customer advised that no buttons were being pressed when the device powered off, and the device was able to be powered back on when the power button was pressed.This issue is patient related; however there was no adverse patient outcome reported by the customer.No further details were provided by the customer.Physio-control made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event, but has been unsuccessful.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8656446
• Report Number: 0003015876-2019-00929
• Device Sequence Number: 13911227
• Product Code: MKJ
• UDI-Device Identifier: 00885074269252
• UDI-Public: 00885074269252
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• 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
• Report Date (Section B): 05/30/2019

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 Catalogue Number: 99400-002505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1