BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEAD-UP TILT TABLE

    MDR report key: 2705324 · Received August 7, 2012

    Report

    Report Number
    1932056-2012-00004
    Event Type
    Other
    Date Received
    August 7, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 6, 2012
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    IXR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORT RECEIVED FROM THE END USER, THERE WAS NO MALFUNCTION OF THE TABLE REPORTED WHICH RELATED TO THE INCIDENT. THE PT WAS LEFT UNATTENDED BY HOSPITAL STAFF, WHICH IS A CLEAR VIOLATION OF PRODUCT SAFETY LABELING PRESENT BOTH ON THE TABLE AND IN THE OWNER'S MANUAL.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT RECEIVED FROM THE CUSTOMER, THE PT WAS LEFT ALONE ON THE HUT TABLE (A CLEAR VIOLATION OF PRODUCT SAFETY LABELING) IN THE PROCEDURE ROOM TO GET DRESSED AFTER A PROCEDURE. THE REPORT STATES THAT THE PT LOST BALANCE AND STEADIED HIS/HER SELF BY PLACING A FOOT ON THE FLOOR. THE PT'S FOOT LANDED ON THE FOOT-SWITCH ACTUATOR CONTROL BUTTON FOR THE REVERSE TRENDELENBURG (HEAD-UP) MOVEMENT CAUSING INADVERTENT HEAD-UP MOVEMENT OF THE TABLE. THE ACTION OF THE HEAD RAISING CAUSED THE PT TO CONTINUE FALLING OFF THE FOOT-END OF THE PRODUCT. THE IMPACT FROM THE FALL CAUSED A BRUISE ON THE PT'S OUTER CHEST NEAR THE LEFT UNDERARM AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD-UP TILT TABLE HUT TABLE IXR MEDICAL POSITIONING, INC. 1211

    Patients

    Seq Age Sex Outcome Treatment
    1