BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET, MOBILE OPERATING ROOM TABLE ALPHAMAXX

    MDR report key: 2437694 · Received January 31, 2012

    Report

    Report Number
    8010652-2012-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    MAQUET GMBH & CO. KG
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CHECKED BY MAQUET FIELD SERVICE TECHNICIAN. THE PROBLEM COULD BE REPRODUCED. BECAUSE THE CUSTOMER HAS ELECTED NOT TO RETURN THIS TABLE TO SERVICE, MAQUET HAS ARRANGED FOR IT TO BE RETURNED TO OUR NJ FACILITY WHERE THE REQUIRED SERVICE AND MECHANICAL EVALUATIONS WILL BE COMPLETED. AN ADDITIONAL FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE AFOREMENTIONED SERVICE. MAQUET INC. 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. EXEMPTION (B)(4).

    Description of Event or Problem · 1

    DURING A SURGERY, THE OPERATOR ACTIVATED THE HAND CONTROL FOR THE TABLE TO RISE. THEN THE TABLE BEGAN TO BEEP (AS IT WAS HAVING ERRORS) AND STARTED TO TILT TOWARD THE PT'S LEFT. THE MOTION COULD BE STOPPED AND THEY CONTINUED WITH THE SURGERY. AFTER THE CASE WAS FINISHED, OPERATING ROOM STAFF ACTIVATED THE TILT FUNCTION OF THE TABLE TO PLACE A ROLLER UNDER THE PT AND SLIDE THEM ONTO THE RECOVERY BED. BUT WHEN THE TILT COMMAND WAS TERMINATED, THE TABLE CONTINUED TO TILT TO THE SIDE CAUSING THE PT TO ALMOST FALL OFF THE BED. THE OPERATING ROOM NURSE SECURED THE PT AND THE STAFF WAS ABLE TO MOVE THE PT FROM THE BED TO THE STRETCHER WITHOUT ANY INCIDENT TO THE PT. HOWEVER THE NURSE SUFFERED A STRAINED BACK, LEFT KNEE AND ARM DURING THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET, MOBILE OPERATING ROOM TABLE ALPHAMAXX TABLE, OPERATING ROOM, AC-POWERED, FQO FQO MAQUET GMBH & CO. KG 1133.22F5

    Patients

    Seq Age Sex Outcome Treatment
    1