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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report their device would not power on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
The customer received a replacement device.The device has not been returned to stryker for evaluation.The cause of the reported issue could not be determined h3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The initial medwatch report indicated in additional mfg narrative: the customer received a replacement device.The device has not been returned to stryker for evaluation.The cause of the reported issue could not be determined.The initial medwatch report should indicate in additional mfg narrative: the device has not been returned to stryker for evaluation.The cause of the reported issue could not be determined.Additional manufacturer narrative: the customer reported this in error and confirmed the device is working properly.
Event or Problem Description
The customer contacted stryker to report their device would not power on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16898815
• Report Number: 0003015876-2023-00824
• Device Sequence Number: 5561713
• Product Code: MKJ
• UDI-Device Identifier: 00883873823644
• UDI-Public: 00883873823644
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown