BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRESS ECHO TABLE

    MDR report key: 1521816 · Received November 2, 2009

    Report

    Report Number
    1932056-2009-00002
    Event Type
    Other
    Date Received
    November 2, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 27, 2009
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INSPECTION OF THE DROP-SECTION WAS COMPLETED BY (B)(6) (A REPRESENTATIVE FROM A THIRD PARTY BIOMEDICAL EQUIPMENT MAINTENANCE COMPANY) WORKING FOR (B)(4)). THE INSPECTION WAS PERFORMED EXACTLY AS INSTRUCTED BY MEDICAL POSITIONING, INC. THE INSPECTION FOUND THE FOLLOWING: BOTH DROP-SECTION LATCHES WERE FULLY FUNCTIONAL AND OPERATING CORRECTLY AND THEY WERE WITHIN NORMAL TOLERANCE. THE DROP-SECTION LATCH ASSEMBLY WAS ABLE TO SUPPORT OVER 200LBS OF WEIGHT WITHOUT FAILURE. NO PHYSICAL DAMAGE FOUND IN THE DROP-SECTION'S MECHANISMS (LATCHES, LATCH RECEIVER BRACKETS, RELEASE LEVER OR HINGE). FURTHER INVESTIGATION BY MEDICAL POSITIONING, INC. FOUND THAT THE PT WAS LEFT UNASSISTED BY THE CLINIC'S STAFF AS SHE WAS EXITING THE TABLE (IT WAS FOUND THAT THE CLINIC'S PROTOCOL IS THAT IF THE PT IS AMBULATORY, THE STAFF IS NOT TO ASSIST THEM WHEN GETTING ON AND OFF THE EXAM TABLE). THIS PROTOCOL IS INCONGRUENT WITH MANUFACTURER LABELING ON THE TABLE WHICH STATES NOT TO LEAVE THE PT UNATTENDED. THE INVESTIGATION ALSO FOUND THAT TABLE PAPER WAS IN USE DURING THE EXAM. THE INSPECTION AND FURTHER INVESTIGATION CONFIRMED THAT THE INCIDENT WAS NOT CAUSED BY A DEFECT IN THE DESIGN OR MANUFACTURE OF THE DROP-SECTION. THIS UNIT HAD BEEN IN USE ON A DAILY BASIS FOR ALMOST 6 YEARS WITHOUT SIMILAR REPORTED INCIDENTS. THE ONLY POSSIBLE CONCLUSION WHICH CAN BE DRAWN IS THAT THE INCIDENT WAS DUE TO IMPROPER USE BY THE END USER, EITHER BECAUSE THE DROP-SECTION WAS NOT FULLY CLOSED PRIOR TO THE END OF THE PROCEDURE OR THE TABLE PAPER IN USE AT THE TIME OF THE INCIDENT WAS ALLOWED TO INTERFERE WITH THE LATCHES' ABILITY TO FULLY ENGAGE THE RECEIVER BRACKETS. IN EITHER CASE THE DROP-SECTION OPERATED NORMALLY PRIOR TO THE INCIDENT AND HAS CONTINUED TO OPERATE NORMALLY AFTER THE INCIDENT.

    Description of Event or Problem · 1

    UPON COMPLETION OF THE STRESS ECHO PROCEDURE, THE SONOGRAPHER CLOSED THE TABLES DROP-SECTION (A SECTION IN THE TABLE THAT HINGES DOWN TO PROVIDE ACCESS TO THE PT'S CHEST DURING THE ECHO PROCEDURE). THE (B)(6) PT WAS LEFT UNASSISTED BY THE CLINIC'S STAFF MEMBER PER THE CLINIC'S OWN PROTOCOL FOR AMBULATORY PTS AND ALLOWED TO EXIT THE TABLE UNDER THE PT'S OWN POWER. LABELING ON THE STRESS ECHO TABLE CLEARLY STATES NOT TO LEAVE PTS UNASSISTED. THE PT THEN SAT UP ON THE TABLE AND PLACED HER HAND ON THE DROP-SECTION TO SUPPORT HER WEIGHT WHILE PUSHING OFF TO STAND UP. AS THE PT WAS PUSHING OFF THE DROP-SECTION, THE DROP-SECTION OPENED CAUSING THE PT TO LOSE HER BALANCE, STRIKING HER HEAD ON ANOTHER PIECE OF EQUIPMENT. THIS INCIDENT CAUSED A BRUISE ON HER HEAD. THE PT WAS GIVEN A COLD PACK AND OBSERVED BY THE MEDICAL STAFF ON-SITE. LATER THAT DAY THE PT WENT TO THE LOCAL EMERGENCY ROOM, WAS EXAMINED AND GIVEN A CLEAN BILL OF HEALTH. THIS INCIDENT COULD NOT BE REPRODUCED BY THE STAFF AT (B)(4). THIS PIECE OF EQUIPMENT WAS MANUFACTURED 12/30/2003 AND USED ON A DAILY BASIS SINCE THEN WITHOUT ANY REPORT OF A SIMILAR INCIDENT OCCURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRESS ECHO TABLE STRESS ECHOCARDIOGRAPHY EXAM TABLE LGX MEDICAL POSITIONING, INC. 2686

    Patients

    Seq Age Sex Outcome Treatment
    1 Other