BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3243120 · Received July 17, 2013

    Report

    Report Number
    3008355164-2013-00161
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT THE ARMS OF THE SURGICAL LIGHT SYSTEM ARE DIFFICULT TO MOVE. HE REPORTED THAT THERE WAS NO DISTANCE BETWEEN THE UPPER AND THE LOWER ARM, CREATING FRICTION BETWEEN THE TWO ARMS. NO INJURIES WERE REPORTED BY THE HOSPITAL. FACTORY REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332719 MAQUET SAS FSY MAQUET SAS PWD77+DFVK3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI