BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS MONITOR

    MDR report key: 18446511 · Received January 3, 2024

    Report

    Report Number
    MW5149779
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 28, 2023
    Report Date
    December 29, 2023
    Manufacturer
    EDAN INSTRUMENTS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BURNING ELECTRICAL SMELL COMING FROM VITAL SIGNS MONITOR, WITH CRACKING AND POPPING NOISES. REMOVED UNIT FROM POLE TO DISCOVER BOTTOM OF CASE TURNING BROWN. REMOVED UNIT FROM FACILITY DUE TO POSSIBLE FIRE HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921915 VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MHX EDAN INSTRUMENTS, INC. M3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention