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

Catalog Number	97400-001371
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
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.However, the customer showed a physio service representative a video of 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 displayed the ¿service needed¿ across the display during a patient event.This is indicative of a potential device lock-up.The customer advised that during a transport of a patient, after hitting a bump in the road, their device display went blank and then ¿service needed¿ appeared on the screen.When this occurred all leds became illuminated and remained lit.After approximately 5 minutes they powered the device off and then back on again, thereafter no further issues were observed.The customer advised that there were no adverse effects to the patient as a result of the reported issue.No further details were provided.Physio-control has made several attempts to contact the customer for further information on the event and patient, 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: 7824772
• Report Number: 0003015876-2018-01406
• Device Sequence Number: 13846459
• Product Code: MKJ
• UDI-Device Identifier: 00883873950982
• UDI-Public: 00883873950982
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• 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): 08/28/2018

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 Catalogue Number: 97400-001371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1