BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAVIEW DM3

    MDR report key: 11089303 · Received December 29, 2020

    Report

    Report Number
    3003294644-2020-00002
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    May 30, 2020
    Report Date
    October 9, 2020
    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 · 1

    END-USER REPORTED THAT THE DEVICE WAS AT THE NURSES STATION AND WAS NO LONGER ON A PATIENT, BUT IT WAS ON AND IT WAS NOT PLUGGED INTO THE WALL, WHEN IT STARTED SMOKING AND FLAMING. THE FIRE WAS EXTINGUISHED AND THE DEVICE WAS MOVED OUTSIDE. PATIENTS WERE MOVED OUT OF THE WARD AS A PRECAUTION DUE TO THE SMELL FROM THE DEVICE. 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
    1555155 ULTRAVIEW DM3 PATIENT PHYSIOLOGICAL MONITOR DXN ZOE MEDICAL, INC. 91330

    Patients

    Seq Age Sex Outcome Treatment
    1