BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET, MOBILE O.R. TABLE, ALPHASTAR

    MDR report key: 3964599 · Received March 5, 2014

    Report

    Report Number
    8010652-2014-00006
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Manufacturer
    MAQUET GMBH AND CO. KG
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) INVESTIGATED THE DEVICE. HE FOUND BOTH PARTS COMPLETELY BROKEN AT PIVOT POINT. MANUFACTURER ANALYSIS OF THE INFORMATION CAPTURED, INDICATES THAT USER ERROR IS THE ROOT CAUSE OF THE BREAKAGE OF THIS TABLE'S LEG SUPPORTS. THE USER APPEARS TO HAVE BEEN OPERATING THE TABLE IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS OUTLINED IN THE TABLE'S USER MANUAL (B)(4). FOR THIS BREAK TO HAVE OCCURRED, THE TABLE LEGS WOULD NEED TO BE SET AGAINST THE FLOOR (OR THE TABLE'S BASE COVER) AND THEN AN OPERATOR WOULD HAVE TO ACTIVATE THE TABLE'S TRENDELENBURG, LEG UP OR HEIGHT FUNCTION. WITH NOWHERE FOR THE LEG TO MOVE, THE HYDRAULICS WOULD CONTINUE TO APPLY PRESSURE. IF REPEATED SEVERAL TIMES THE SUPPORT CAN BREAK. PREVIOUS TESTING UPON THE ALPHASTAR SERIES TABLE HAS SHOWN THAT THE PATIENT'S WEIGHT ISN'T SUFFICIENT TO CAUSE A BREAK OF THE LEG SECTION. THESE TABLES WERE TESTED IN THIS CONFIGURATION WITH FOUR TIMES THE PERMISSIBLE LOAD (UP TO 450KG WITH NO ISSUES). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IMP - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131580 MAQUET, MOBILE O.R. TABLE, ALPHASTAR TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH AND CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1