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

Model Number	20
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and verified the issue of device not completing boot-up cycle.Along with other unrelated repairs, it was recommended that the system pcb assembly be replaced to address the issue with device not completing boot-up cycle, however a quote was provided to the customer.Per customer request, the device was returned to the customer without completed repairs.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.During evaluation, physio-control observed that the device would not complete boot up during initial power on.The device would show a splash screen and would not advance to the boot cycle from there.In this state the device would not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.During evaluation, physio-control observed that the device would not complete boot up during initial power on.The device would show a splash screen and would not advance to the boot cycle from there.In this state the device would not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
During further evaluation, physio-control isolated the cause to the therapy board, but no further root cause was able to be determined.

• 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: 10024958
• Report Number: 0003015876-2020-00604
• Device Sequence Number: 14192053
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: 99402-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1