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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and observed that the device powered off only when a battery was installed in battery well 2 and no battery in battery well 1.Physio observed that a battery pin in battery well 2 was pushed into the battery terminal, which caused the device to lose power.The rear enclosure was replaced for an unrelated issue, however the rear enclosure contained new battery pins.Physio also observed a burn on the battery wire harness assembly and the assembly was replaced.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.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 their device powered off by itself shortly after being powered on.The customer advised that with batteries installed in battery well 1 and 2, the device would power on, but then shortly thereafter the device would power off.With a battery in well 2 only, the device would also power on but then power off.With a battery in well 1 only, the device powered on with no issues.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself shortly after being powered on.The customer advised that with batteries installed in battery well 1 and 2, the device would power on, but then shortly thereafter the device would power off.With a battery in well 2 only, the device would also power on but then power off.With a battery in well 1 only, the device powered on with no issues.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the rear enclosure.It was determined that the cause of the reported issue was due to a missing battery pin insert, which likely caused an intermittent connection between the battery and the 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: 7996335
• Report Number: 0003015876-2018-01769
• Device Sequence Number: 11107903
• Product Code: MKJ
• UDI-Device Identifier: 00883873911785
• UDI-Public: 00883873911785
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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,Followup
• Report Date (Section B): 12/10/2018

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: 99577-001241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1