MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATIC EXTERNAL DEFIBRILLATOR (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	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and duplicated the reported issue.Physio replaced the device's w18 flex cable to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device would not complete the boot up process.In this state the device would not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
Event or Problem Description
The customer contacted physio-control to report that their device would not complete the boot up process.In this state the device would not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed flex assembly-ui and determined that the root cause of the issue was broken traces of the flex at a stress points for contacts c2 (usb+) & c3 (usb-).This would result in a loss of communication between the system controller and the user interface, and device not being able to complete the boot cycle.

• Brand Name: LIFEPAK® 20 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9604356
• Report Number: 0003015876-2020-00098
• Device Sequence Number: 2928467
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/27/2020

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: 01/03/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1