BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET OR TABLE SYSTEM

    MDR report key: 5872476 · Received August 12, 2016

    Report

    Report Number
    8010652-2016-00018
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 15, 2016
    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

    A MAQUET-SERVICE-TECHNICIAN WAS ON SITE AND INSPECTED THE AFFECTED SYSTEM. NO MALFUNCTION AND NO UNINTENDED MOVEMENT COULD BE DETECTED. ALL FUNCTIONS WERE ONLY POSSIBLE BY USING THE IR REMOTE CONTROL OR THE WALL PANEL. ADDITIONAL FUNCTIONAL TESTS ALSO DIDN'T SHOW ANY FAILURE. MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A UNINTENDED MOVEMENT OF THE TABLE WHILE A PATIENT WAS LYING ON THE TABLE TOP. NO INJURY WAS REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524525 MAQUET OR TABLE SYSTEM TABLE, OPERATING-ROOM, AC-POWERED FQO KEHLER STRASSE 31

    Patients

    Seq Age Sex Outcome Treatment
    1