BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET MODULAR UNIVERSAL TABLE TOP

    MDR report key: 6150823 · Received December 7, 2016

    Report

    Report Number
    8010652-2016-00030
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    October 30, 2016
    Report Date
    February 28, 2017
    Manufacturer
    KEHLER STRASSE 31
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE TOP HAS BEEN SEND TO (B)(4) FOR INVESTIGATION AND REPAIR. DURING THE INVESTIGATION MAQUET FOUND THAT THE CENTRAL HOUSING OF THE TABLE TOP WAS BROKEN ON TWO LOCATIONS TOWARD THE HEAD SIDE OF THE TABLE TOP. COLLISION WITH AN OBSTACLE BELOW THE TABLE TOP WHEN ADJUSTING THE HEIGHT (FOR EXAMPLE WHEN THE TRANSPORTER IS NOT MOVED COMPLETELY UNDER THE COLUMN FOR THE POSTOPERATIVE TRANSFER) CAN CAUSE THIS TYPE OF REPORTED MALFUNCTION. MAQUET FOUND MARKS ON THE UNDERSIDE OF THE TABLE TOP CONSISTENT WITH COLLISION DAMAGE. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE TABLE TOP IN QUESTION WAS REQUESTED FOR INVESTIGATION. AT THE TIME OF THIS REPORT HOWEVER THE TABLE TOP HAS NOT YET BEEN ARRIVED SO THAT THE INVESTIGATION HAS NOT YET BEEN CARRIED OUT. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT WAS POSITIONED ON THE TABLE TOP. DURING TRANSFER OF THE TABLE TOP TO THE COLUMN, THE TABLE TOP WAS MOVED TO THE HEAD END. THIS RESULTED IN AN OVERLOAD AND BREAK OF THE TABLE TOP AT THE MOUNTING. THE TABLE TOP TILTED FORWARD, AND WAS INTERCEPTED BY THE STAFF SO THAT NO PATIENT INJURY OCCURRED. NO INJURY WAS REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800935 MAQUET MODULAR UNIVERSAL TABLE TOP TABLE, OPERATING-ROOM, AC-POWERED FQO KEHLER STRASSE 31 1150.30B0

    Patients

    Seq Age Sex Outcome Treatment
    1