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	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 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.
Additional Manufacturer Narrative
The charge-pak was returned with the device.Physio-control evaluated the device and the reported issue was verified.The device would not power on.The charge-pak had had a shorting plug installed, and then removed.The root cause of the reported issue is that the hlc's discharged rapidly into the depleted charge-pak cells.The device was opened, and then an internal physical inspection was performed.No discrepancies were observed.The device was destructively tested.The customer received a replacement device.
Event or Problem Description
The 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: 9142550
• Report Number: 0003015876-2019-01642
• Device Sequence Number: 3046218
• Product Code: MKJ
• UDI-Device Identifier: 00883873823644
• UDI-Public: 00883873823644
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/02/2020

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: 99427-000129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1