BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET, OPERATING TABLE TOP

    MDR report key: 1912409 · Received November 16, 2010

    Report

    Report Number
    8010652-2010-00008
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MAQUET GMBH & CO. KG
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAD REST ADAPTER SEPARATED FROM THE CARBON TABLE TOP. THIS HAPPENED NOT DURING A SURGICAL INTERVENTION. A MAQUET FIELD SVC TECH (FST) INVESTIGATED THE TABLE AT THE HOSPITAL. THE FST OBSERVED THAT THE ADHESIVE BOND THAT CONNECTS THE ADAPTER TO THE TABLE TOP HAD FAILED. THE TABLE TOP FULFILLS THE REQUIREMENTS ACCORDING TO (B)(4). ALSO A MECHANICAL STRENGTH TEST WITH SAFETY FACTOR 6 FOR THE HEAD REST INTERFACE HAS BEEN DONE. THE TABLE TOP IS 9 YRS OLD. POSSIBLY OVERLOAD OR COLLISIONS ARE THE ROOT CAUSE FOR THE BREAK. MAQUET HAS RECOMMENDED THAT THE CUSTOMER REPLACE THE DAMAGED CARBON FIBER PLATE OF THE TABLE TOP. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THE REPORT.

    Description of Event or Problem · 1

    THE HEAD REST ADAPTER HAS SEPARATED FROM THE CARBON FIBER TABLE TOP. THIS HAPPENED NOT DURING A SURGICAL INTERVENTION, SO THERE WAS NO PT ON THE TABLE TOP. NO INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET, OPERATING TABLE TOP TABLE, RADIOLOGIC, CODE KXJ KXJ MAQUET GMBH & CO. KG 1150.16B0

    Patients

    Seq Age Sex Outcome Treatment
    1