BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2217036 · Received August 2, 2011

    Report

    Report Number
    9710055-2011-00005
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN VISITED THE HOSPITAL AND EVALUATED THE DEVICE. HE FOUND THAT THE METAL STRUCTURE OF THE ONDAL ACROBAT 2000, DOUBLE FORK SPRING ARM HAD BROKEN AT THE JUNCTION WITH THE CUPOLA. HE REPLACED THE BROKEN SPRING ARM AND VERIFIED ITS FIT FOR USE. THE TECHNICIAN THEN INSPECTED THE OTHER MAQUET SIMILAR CONFIGURATIONS AT THIS FACILITY AND VERIFIED THERE WERE NO ADDITIONAL ISSUES. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH A DEVICE CORRECTION: FDA NUMBER Z-0182-188-2010, (B)(4). MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SPRING ARM BROKE DURING A SURGERY. THE CUPOLA WAS RETAINED BY THE CABLES. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FTD MAQUET SAS HANAULUX 2000

    Patients

    Seq Age Sex Outcome Treatment
    1