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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control further evaluated the loaner device and verified the reported issue.Physio isolated the cause of the reported issue to the user interface pcb assembly.The pcb will be replaced to resolve this issue.After other unrelated repairs are completed, and proper device operation is observed through functional and performance testing, the device will be returned to the customer for use.
Event or Problem Description
A physio-control service representative was performing routine maintenance on a loaner device and observed non-critical event codes logged in the memory of the device.Upon performing repairs it was observed that the device was unable to boot complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control isolated the reported issue to the user interface pcb assembly.However, the device could not be repaired and was scrapped.
Event or Problem Description
A physio-control service representative was performing routine maintenance on a loaner device and observed non-critical event codes logged in the memory of the device.Upon performing repairs it was observed that the device was unable to boot complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no 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: 10979671
• Report Number: 0003015876-2020-01847
• Device Sequence Number: 3034151
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 99402-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1