BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS NEWBORN HEART RATE MONITOR

    MDR report key: 20187956 · Received September 11, 2024

    Report

    Report Number
    3018685978-2024-00001
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 12, 2024
    Manufacturer
    SUREPULSE MEDICAL LIMITED
    Product Code
    DQA
    PMA / PMN Number
    K201887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY USING THE SUREPULSE VS NEWBORN HEART RATE MONITOR REPORTED THAT ONE OF THE DEVICES WOULD NOT TURN ON. THEY REPORTED THAT AFTER SUCCESSFUL USE, THE DEVICE WAS LEFT NOT PLUGGED IN AND THE BATTERY SUBSEQUENTLY FULLY DRAINED. THE DEVICE WAS NOT BEING USED. AFTER THAT POINT THE DEVICE HAS NOT BEEN ABLE TO BE TURNED BACK ON EVEN CONNECTED TO ITS MAINS POWER SUPPLY. THE USER FACILITY ATTEMPTED TO REPAIR THE DEVICE BY SWAPPING THE BATTERY BUT HAVE BEEN UNABLE TO GET IT TO TURN ON AGAIN. THERE IS NO FURTHER INFORMATION AT PRESENT AND WE HAVE NOT BEEN ABLE TO INSPECT THE DEVICE AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601773 VS NEWBORN HEART RATE MONITOR HEART RATE MONITOR DQA SUREPULSE MEDICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown