BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3150221 · Received May 1, 2013

    Report

    Report Number
    3008355164-2013-00106
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF A PROCEDURE, THE NURSE ATTEMPTED TO REPOSITION THE LIGHT HEAD TO ALLOW PT TRANSPORT WHEN IT DETACHED AND FELL TO THE FLOOR. THE NURSE WAS STRUCK IN THE HANDS BUT SUFFERED NO INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190743 MAQUET SAS NA FTD MAQUET SAS HANAULUX 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI