BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    MDR report key: 23100128 · Received September 19, 2025

    Report

    Report Number
    3004123209-2025-00240
    Event Type
    Death
    Date Received
    September 19, 2025
    Date of Event
    August 17, 2025
    Report Date
    November 19, 2025
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A HEARTSINE SERVICE REPRESENTATIVE PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER¿S DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. THERE WAS NO ISSUE WITH THE DEVICE AND FITMENT OF THE TEST PAD-PAK WITHIN THE DEVICE. IT IS LIKELY THAT THE REPORTED ISSUE RELATED THE INSTALLATION OF THE PAD-PAK, E.G., THE PAD-PAK INITIALLY BEING INCORRECTLY SEATED WITHIN THE DEVICE, AS THE CUSTOMER REPORTED THE DEVICE WORKING AFTER ¿AFTER SHAKING THE UNIT AND TURNING IT UPRIGHT¿. HOWEVER, AS IT WAS REPORTED THE RETURNED PAD-PAK WAS DISCARDED AFTER USE, IT WAS NOT RETURNED TO HEARTSINE AND IS THEREFORE UNAVAILABLE FOR INSPECTION. THE DEVICE WAS ARCHIVED BY HEARTSINE. THE CUSTOMER WILL BE PROVIDED WITH REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEW WAS PERFORMED AND IT IS UNKNOWN IF THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME. HEARTSINE TECHNOLOGIES LTD HAS RECEIVED THE DEVICE FOR EVALUATION. WE WILL COMMUNICATE OUR FINDINGS REGARDING THE CAUSE OF THIS EVENT IN OUR FINAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969484 UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD HDF3500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death