BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 15282573 · Received August 24, 2022

    Report

    Report Number
    15282573
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 28, 2022
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CHARGE NURSE REPORTED THAT WHEN THE PATIENT MONITOR IS POWERED OFF A BURN LIKE SMELL WAS COMING FROM THE MONITOR. AFTER BIOMED TECH CAREFULLY INVESTIGATED, THEY FOUND OUT THAT THE POWER CORD WOULD START GETTING HOT WHEN YOU TOUCHED IT AND FELT LIKE IT WOULD MELT AND THAT WAS CAUSING ELECTRICAL WIRES TO SPARK, SO THEY REPLACED POWER CORD AND NOTIFIED MANUFACTURER. MANUFACTURER RESPONSE FOR MONITOR, VITAL SIGNS-MONITORING EQUIPMENT, 68MXTX, PER SITE REPORTER. REQUESTED TO SEND DAMAGED POWER CORD TO HILL ROM AND WE SEND TO THEM FOR EVALUATION, BUT THIS IS THE FOURTH POWER CORD TO SET ON FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434164 WELCH ALLYN, INC. MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI WELCH ALLYN, INC. 901060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown