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

Model Number	EXPRESS
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control advised the customer that there is no service repair available or repair parts for their device and it is no longer under warranty.Physio recommended that the customer remove the device from service and a replacement device be obtained.The customer confirmed that the device has been permanently removed from service.The device has not been returned to physio-control for an evaluation.The cause of the reported event could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
A customer contacted physio-control to report that their device was showing all three icons (attention, charge-pak and service wrench).With all three icons illuminated, the device may not have sufficient power available to deliver effective defibrillation therapy to a patient, if it was needed.There was no patient use associated with the reported event.

• 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: 8392920
• Report Number: 0003015876-2019-00386
• Device Sequence Number: 16556969
• Product Code: MKJ
• UDI-Device Identifier: 00883873823682
• UDI-Public: 00883873823682
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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: 99427-000002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1