MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
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 while their device was monitoring a patient, the device powered itself off.The ambulance was in motion at the time the shut down occurred.There was no adverse effect to the patient due to the reported issue.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue through the device's electronic records.Physio replaced the battery pins, power pcb assembly and battery wire harness to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further examined the removed power pcb assembly and battery wire harness assembly and determined that the likely cause of the reported issue was excessive wear on connectors j11/p11 on the battery wire harness assembly and the power pcb assembly.The excessive wear caused increased resistance of the connector contacts which resulted in an excessive voltage drop at the contacts when certain functions are activated.The excessive voltage drop at the contacts triggers the power fail detector circuit on the power board.Triggering the power fail detector circuit will cause the device to either shutdown or power cycle.
Event or Problem Description
The customer contacted physio-control to report that while their device was monitoring a patient, the device powered itself off.The ambulance was in motion at the time the shut down occurred.There was no adverse effect to the patient due to the reported issue.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 8201593
• Report Number: 0003015876-2018-02208
• Device Sequence Number: 16682815
• Product Code: MKJ
• UDI-Device Identifier: 00883873911723
• UDI-Public: 00883873911723
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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: 99577-001247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1