BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAVIEW DM3

    MDR report key: 15820624 · Received November 17, 2022

    Report

    Report Number
    3003294644-2022-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ZOE MEDICAL, INCORPORATED
    Product Code
    DXN
    PMA / PMN Number
    K093802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    END USER REPORTED A NEAR FIRE ASSOCIATED WITH A POWER SUPPLY FOR AN ULTRAVIEW DM3 PATIENT MONITOR. IT IS NOT KNOWN WHETHER THE POWER CORD WAS CONNECTED TO THE MONITOR AT THE TIME. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS OBSERVED THAT THE POWER SUPPLY WAS PARTIALLY MELTED AT THE POINT WHERE A COUNTRY-SPECIFIC PLUG WAS ATTACHED TO THE MAIN BODY OF THE POWER SUPPLY. THE LIKELY CAUSE OF THIS EVENT WAS THAT THE COUNTRY-SPECIFIC PLUG HAD WORKED LOOSE FROM ITS CONNECTION TO THE MAIN BODY OF THE POWER SUPPLY, CREATING A SPARK THAT MELTED THE SURROUNDING PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704877 ULTRAVIEW DM3 PATIENT PHYSIOLOGICAL MONITOR DXN ZOE MEDICAL, INCORPORATED 91330

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown