BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM

    MDR report key: 2870158 · Received December 6, 2012

    Report

    Report Number
    8010042-2012-00148
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART HAS BEEN REQUESTED BACK FOR INVESTIGATION BUT HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPPORT ARM GOT DISENGAGED FROM THE RAIL OF THE MOBILE CART AND STRUCK THE PT, BUT, THERE WAS NO PT HARM. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI