MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK EXPRESS® DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	EXPRESS
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio determined that the cause of the reported issue was due to a shorted capacitor, designator c76, on the digital pcb assembly.The customer received a replacement device.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device unexpectedly powered off while it was being tested.

• Brand Name: LIFEPAK EXPRESS® DEFIBRILLATOR
• 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: 8597805
• Report Number: 0003015876-2019-00823
• Device Sequence Number: 1667360
• Product Code: MKJ
• UDI-Device Identifier: 00883873823644
• UDI-Public: 00883873823644
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• 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
• Report Date (Section B): 05/09/2019

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: Lay User/Patient
• Device Model Number: EXPRESS
• Device Catalogue Number: 99427-000129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1