MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control obtained the customer's device for evaluation and downloaded its electronic patient records for review.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 unexpectedly when the code summary button was pressed.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 unexpectedly when the code summary button was pressed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control reviewed the downloaded electronic records from the device and was able to verify the reported issue.Physio-control observed that there were four (4) unexpected losses of power on the day of the event, three of which occurred while attempting to print the code summary.Physio-control then performed a voltage drop test which indicated that the cause of the reported issue was worn battery pins.Physio-control then replaced the device's battery pins and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Common Device Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 8446477
• Report Number: 0003015876-2019-00509
• Device Sequence Number: 19393721
• Product Code: MKJ
• UDI-Device Identifier: 00883873911723
• UDI-Public: 00883873911723
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 05/14/2019

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: 03/09/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1