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

Model Number	20
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and verified the reported issue.Physio replaced the device's system controller pcb assembly and user interface pcb assembly and the reported issue was no longer duplicated.Unrelated repairs were completed.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio further evaluated the removed system controller pcb assembly and user interface pcb assembly and was not able to replicate any of the reported issues.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device was not booting properly.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.

• Brand Name: LIFEPAK 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: 10383134
• Report Number: 0003015876-2020-01021
• Device Sequence Number: 1241193
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• 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): 08/09/2020

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: 20
• Device Catalogue Number: 99402-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1