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

Catalog Number	99400-003505
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported failure 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 their device powered itself off several times during patient use.They were able to power the device back on each time.There were no adverse effects to the patient as a result of the reported issue.No further details about the patient or the event were provided.Physio-control has made multiple attempts to contact the customer in order to obtain additional information on the patient; however, no response has been received.
Event or Problem Description
The customer contacted physio-control to report that their device powered itself off several times during patient use.They were able to power the device back on each time.There were no adverse effects to the patient as a result of the reported issue.No further details about the patient or the event were provided.Physio-control has made multiple attempts to contact the customer in order to obtain additional information on the patient; however, no response has been received.
Additional Manufacturer Narrative
It was reported to the field service representative that the customer was not seating the batteries all the way in, which was the cause of the reported issue.The device was not returned to physio-control for an evaluation.However the most likely cause of the reported issue is that the device batteries were not properly installed into the device (use error).

• Brand Name: LIFEPAK® 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: 8392918
• Report Number: 0003015876-2019-00385
• Device Sequence Number: 13847053
• Product Code: MKJ
• UDI-Device Identifier: 00885074857749
• UDI-Public: 00885074857749
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 99400-003505
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1