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

Model Number	EXPRESS
Medical Device Problem Codes	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device's battery is defective.As a result, the device may be unable to power on to provide defibrillation therapy, if it is 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's battery is defective.As a result, the device may be unable to power on to provide defibrillation therapy, if it is needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the device's charge-pak battery charger and verified the reported issue.Physio determined that the cause of the reported issue was due to correct memory on the charge-pak.The customer received a replacement charge-pak to resolve the reported issue.

• 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: 9236502
• Report Number: 0003015876-2019-01747
• Device Sequence Number: 2524018
• Product Code: MKJ
• UDI-Device Identifier: 00883873823835
• UDI-Public: 00883873823835
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup
• Report Date (Section B): 01/09/2020

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: Lay User/Patient
• Device Model Number: EXPRESS
• Device Catalogue Number: 97403-000019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1