BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2985043 · Received February 19, 2013

    Report

    Report Number
    9710055-2013-00006
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING AND THE RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT DURING AN OPERATION, THE CUPOLA DETACHED FROM ITS SPRING ARM BUT REMAINED CONNECTED TO THE CONFIGURATION BY ITS CABLES. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72820 MAQUET SAS FTD MAQUET SAS HLX 2005ITV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI