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

Model Number	EXPRESS
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.The cause of the reported issue was not determined.The customer will receive a replacement device.
Event or Problem Description
Physio-control received a report from the customer that the device cannot be turned on; they reported, "when on button is pressed, it says "call for help now", then shuts off." in this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient involvement associated to the event.
Event or Problem Description
Physio-control received a report from the customer that the device cannot be turned on; they reported, "when on button is pressed, it says "call for help now", then shuts off." in this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient involvement associated to the event.
Additional Manufacturer Narrative
The root cause of the reported failure is physical damage to the chargepak flex cable connector.

• 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: 11815449
• Report Number: 0003015876-2021-01048
• Device Sequence Number: 14389682
• Product Code: MKJ
• UDI-Device Identifier: 00883873823644
• UDI-Public: 00883873823644
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 04/26/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1