BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 1349145 · Received December 22, 2008

    Report

    Report Number
    2126677-2008-00105
    Event Type
    Malfunction
    Date Received
    December 22, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) FOUND THE SUPPLY FUSE TO THE MAIN INPUT POWER TRANSFORMER (F3) WAS OPEN, WHICH SHUT OFF THE TABLE CONTROL AND BRAKES. FOLLOWING THE FUSE F3 REPLACEMENT, ANOTHER FUSE FAILURE OCCURRED LATER IN THE DAY DURING PREVENTATIVE MAINTENANCE. THE FE'S INVESTIGATION REVEALED THAT THE TABLE POWER INPUT TOROID TRANSFORMER WAS THE LIKELY CAUSE OF THE SECOND FAILURE. THE FE REPLACED THE TOROID TRANSFORMER AND VERIFIED THAT THE REPLACEMENT FIXED THE TABLE FLOAT. THE SITE HAS EXPERIENCED NO SIMILAR PROBLEM SINCE THE INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE WHEN THE TECHNOLOGIST RELEASED THE FOOT PEDAL DUE TO POWER LOSS, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LATERAL AND LONGTITUDINAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC 45434285

    Patients

    Seq Age Sex Outcome Treatment
    1