MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
A customer contacted physio-control to report that their device had illuminated its service led and powered off unexpectedly during use.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
The customer has not agreed to return the device for the investigation.The device was not returned to redmond.The reported issue could not be verified, and root cause could not be determined.
Event or Problem Description
A customer contacted physio-control to report that their device had illuminated its service led and powered off unexpectedly during use.There were no reports of patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 20 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: 11599506
• Report Number: 0003015876-2021-00672
• Device Sequence Number: 3617169
• Product Code: MKJ
• UDI-Device Identifier: 00883873813744
• UDI-Public: 00883873813744
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 20
• Device Catalogue Number: 99402-000016
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2019
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1