BEUDAMED
    FDA Adverse Event Other Summary report: N

    GSPM TABLE

    MDR report key: 1032482 · Received February 12, 2008

    Report

    Report Number
    1932056-2007-00006
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    December 13, 2007
    Report Date
    December 27, 2007
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT RESULTED FROM WELD FAILURE. WHILE LESS THAN 0.02% WELDS HAVE FAILED, THE INCIDENCE OF FAILURE IN 2004 IS HIGHER THAN IN OTHER YEARS. FOR THAT REASON, ALL CUSTOMERS WITH MODELS WHO HAVE REPORTED WELD FAILURE, AND ARE FROM BATCHES OF STEEL USED IN 2004, WILL BE CONDUCTED AND AN UPGRADE WILL BE INSTALLED TO ENSURE NO FAILURES IN THE FUTURE.

    Description of Event or Problem · 1

    PAIN MANAGEMENT TABLE "BROKE" WITH PATIENT ON TABLE. TABLE WENT FROM HORIZONTAL TO 45 DEGREES HEAD DOWN. PATIENT SLID OFF TABLE. THE PATIENT DESCRIBED THE EVENT AS CAUSING A "JOLT" TO HIS RIGHT ARM AND SHOULDER. HE WAS TAKEN TO THE EMERGENCY ROOM FOR EVAL, BUT THE EXTENT OF HIS INJURIES IS UNKNOWN. IT WAS DISCOVERED THAT THE LOWER TRENDELENBURG ACTUATOR MOUNT HAD BROKEN AWAY FROM THE FRAME. THIS CAUSED THE HEAD END OF THE TABLE TO FALL SUDDENLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSPM TABLE GENERAL SURGERY & PAIN MANAGEMENT TABLE FQO MEDICAL POSITIONING, INC. 60326

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other