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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.   physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio replaced the device's battery pins as a precaution.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly lost power while in use with a patient three times.This issue is patient related; however there was no adverse event reported.

• 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: 11016996
• Report Number: 0003015876-2020-01886
• Device Sequence Number: 2875525
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 99577-001247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR