BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 176

    MDR report key: 3142309 · Received May 21, 2013

    Report

    Report Number
    3008355164-2013-00128
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE ATTENDANT WAS TREATING THE PT WITH HIS BACK TO THE VENTILATOR AND SUPPORT ARM, HE FELT THE SUPPORT ARM HIT HIS BACK. HE SUBSEQUENTLY FOUND THE SUPPORT ARM BROKEN AT THE "SHORT SEGMENT" JOINT BUT THE ACTUAL BREAK IS ON THE LONG ARM SIDE. THERE WAS NO REPORTED HARM. (B)(4). REF NUMBER: 8010042-2013-00079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225213 SUPPORT ARM 176 IOY MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI