BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAVIEW DM3

    MDR report key: 17299120 · Received July 11, 2023

    Report

    Report Number
    3003294644-2023-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 4, 2023
    Report Date
    July 10, 2023
    Manufacturer
    ZOE MEDICAL, INC.
    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 THAT THE DEVICE COMBUSTED AND HAD TO BE PUT OUT WITH A FIRE EXTINGUISHER. THE DEVICE WAS CHARGING IN THE HALLWAY AND WAS NOT CONNECTED TO A PATIENT AT THE TIME OF THE EVENT. THE USER REPORTED THAT THEY HEARD A "POP" AND THEN THE DEVICE CAUGHT FIRE. THE DEVICE WAS TAKEN OUTSIDE AND SPRAYED WITH A FIRE EXTINGUISHER. THE LIKELY CAUSE OF THE FIRE WAS A THERMAL RUNAWAY IN ONE OF THE BATTERY CELLS. THE CAUSE OF THE THERMAL RUNAWAY IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586808 ULTRAVIEW DM3 PATIENT PHYSIOLOGICAL MONITOR DXN ZOE MEDICAL, INC. 91330

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown