BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3040356 · Received March 26, 2013

    Report

    Report Number
    9710055-2013-00012
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MAWUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Removal / Correction Number
    Z-0182/188-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) VISITED THE HOSPITAL AND FOUND THE FRONT PIVOT OF THE SPRING ARM BROKEN AT THE WELD SEAM. THE FST REPLACED THE BROKEN SPRING ARM WITH A NEW ONE AND INSPECTED THE BALANCE OF THE MAQUET SPRING ARMS AT THIS FACILITY. NO ADDITIONAL WELD SEAM ISSUES WERE REPORTED. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. (B)(4). (B)(4) 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 A SPRING ARM BROKE DURING THE CLEANING PROCEDURE. THE CUPOLA WAS HELD TO THE SPRING ARM BY ITS CABLE. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123933 MAQUET SAS FTD MAWUET SAS HLX 2005I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI