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	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device but was unable to duplicate the reported issue.Physio downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced inappropriate loss of power.Physio replaced the battery pins as a precaution.Proper device operation was observed through functional and performance testing.The device will be 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 would randomly reset itself, powering off and on.After several cycles of this, the device would remain and function normally.In this state defibrillation therapy may be delayed or unavailable if needed.There was no patient use associated with the reported event.

• 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: 9614091
• Report Number: 0003015876-2020-00104
• Device Sequence Number: 14122733
• Product Code: MKJ
• UDI-Device Identifier: 00883873871645
• UDI-Public: 00883873871645
• 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
• Report Date (Section B): 01/21/2020

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: 99577-001962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1