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	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and verified the reported issue.Physio determined that the power pcb assembly should be replaced as a precaution.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
The customer contacted physio-control to report that their device will not power on correctly, and that they must repeatedly push the on button.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.
Additional Manufacturer Narrative
Additional information: physio-control replaced the power pcb assembly.After the device passed functional and performance inspection, it was returned to the customer.Further evaluation of the removed power pcb assembly was unable to replicate the issue.Further root cause could not be determined.Corrected data: section h10 additional mfg narrative of the initial medwatch report indicated: physio determined that the power pcb assembly should be replaced as a precaution.Section h10 additional mfg narrative of the initial medwatch report should indicate: physio determined that the power pcb assembly should be replaced.
Event or Problem Description
The customer contacted physio-control to report that their device will not power on correctly, and that they must repeatedly push the on button.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.
Event or Problem Description
The customer contacted physio-control to report that their device will not power on correctly, and that they must repeatedly push the on button.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.
Additional Manufacturer Narrative
Later, the device was returned for same issue.Physio-control evaluated the issue and replaced the therapy pcba as well.The device passed functional and performance testing and was returned to the customer.During further evaluation of the removed therapy pcb assembly, physio was also unable to replicate the issue.No root cause could 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: 10020131
• Report Number: 0003015876-2020-00599
• Device Sequence Number: 2501994
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 08/26/2020

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: 99402-000065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 06/14/2020; 08/01/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/19/2020; 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1