BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    MDR report key: 19634273 · Received June 28, 2024

    Report

    Report Number
    3004123209-2024-00101
    Event Type
    Death
    Date Received
    June 28, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 14, 2024
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE'S INVESTIGATION FOUND THE ROOT CAUSE OF THE REPORTED FAULT TO BE FAILURE OF SWITCH Q9 AND Q13. UPON RECEIPT, THE REPORTED FAULT WAS CONFIRMED. WHEN Q9 AND Q13 WERE REPLACED, THE FAULT COULD NOT BE REPLICATED. AFTER THE COMPONENTS WERE REPLACED, THE DEVICE UNDERWENT EXTENSIVE TESTING OF ALL CRITICAL FUNCTIONS, PERFORMING TO SPECIFICATION THROUGHOUT. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AND THE CUSTOMER ISSUED WITH A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 0

    HEARTSINE TECHNOLOGIES LTD HAS RECEIVED THE DEVICE FOR EVALUATION. WE WILL COMMUNICATE OUR FINDINGS REGARDING THE CAUSE OF THIS EVENT IN OUR FINAL REPORT. HEARTSINE CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE THROUGH THE FORWARD HEART'S PROGRAM. A REVIEW OF THE EVENT DATA SHOWED THE DEVICE WAS UNABLE TO DELIVER SHOCK. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE THROUGH THE FORWARD HEART'S PROGRAM. A REVIEW OF THE EVENT DATA SHOWED THE DEVICE WAS UNABLE TO DELIVER SHOCK. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214657 UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ HEARTSINE TECHNOLOGIES LTD 300P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death