BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOLOGICAL MONITOR QUBE

    MDR report key: 15879117 · Received November 28, 2022

    Report

    Report Number
    MW5113515
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    November 15, 2022
    Report Date
    November 25, 2022
    Manufacturer
    SPACELABS HEALTHCARE (WASHINGTON), INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PLUG AT THE BASE OF THE MONITOR BEGAN TO SPARK/SMOKE WHILE IN USE IN A PATIENT'S ROOM. IT WAS NOT THE PLUG INTO THE WALL, BUT THE PLUG THAT WAS MOUNTED ON THE POLE OF THE UNIT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330302 PHYSIOLOGICAL MONITOR QUBE MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX SPACELABS HEALTHCARE (WASHINGTON), INC. 91390

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Male Required Intervention