BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHAMPAINE

    MDR report key: 977401 · Received August 16, 2007

    Report

    Report Number
    3019090-2007-00003
    Event Type
    Other
    Date Received
    August 16, 2007
    Date of Event
    June 1, 2007
    Report Date
    July 23, 2007
    Manufacturer
    GETINGE USA, INC, FKA MDT DIAGNOSTIC CO
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, THE FACILITY REPORTED THE TABLE WAS BEING USED IN THE NORMAL POSITION; PT WAS SUPINE; NO TABLE FUNCTIONS WERE BEING ACTIVATED AT THE MOMENT AND THE LAST FUNCTION USED WAS TO RAISE THE HEIGHT OF THE TABLE. THE PT WAS BEING MOVED APPROX 1 MINUTE AFTER THE TABLE WAS RAISED. INSPECTION BY GETINGE SERVICE REP AND THE HOSPITAL'S OR TECH DETERMINED THAT THERE WAS NOTHING WRONG WITH THE TABLE AND ITS OPERATION WAS PER SPECIFICATIONS. BASED UPON LIMITED INFO NOTED AND PROVIDED, IT WAS DETERMINED THAT THE TILTING UP OF THE TABLE BASE HAPPENED DURING PT TRANSFER PROCESS TO A TRASPORTING STRETCHER. THE SHIFTING OF THE PATIENT'S CENTER OF GRAVITY OR POSSIBLY OTHER UNK FORCES WERE PLACED ON THE TABLE LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. THE HOSPITAL'S PROCESS IS TO ROLL THE PT TOWARD THE HANDLER AND STRETCHER, USING A TRANSFER BOARD BETWEEN THE TABLE AND STRETCHER AND WAS STATED TO HAVE BEEN USED SUCCESSFULLY FOR YEARS. NOT MINIMIZING THE DISTANCE BETWEEN THE OR TABLE AND THE STRETCHER COULD HAVE CREATED OR CONTRIBUTED TO THE CONDITIONS FOR THIS TO HAPPEN. IN CONCLUSION, THE ENTIRE SITUATION, BEFORE AND DURING THE INCIDENT, REMAIN UNCLEAR EVEN AFTER COMMUNICATIONS WITH THE FACILITIES PERSONNEL.

    Description of Event or Problem · 1

    AS PT WAS BEING REMOVED FROM THE TABLE, IT TILTED 4" OFF THE FLOOR (NO HARM TO THE PT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMPAINE FQO FQO GETINGE USA, INC, FKA MDT DIAGNOSTIC CO 5100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR