BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASSCAN TABLE MODEL 2184

    MDR report key: 1474617 · Received September 1, 2009

    Report

    Report Number
    1932056-2009-00001
    Event Type
    Other
    Date Received
    September 1, 2009
    Date of Event
    July 26, 2007
    Report Date
    September 1, 2009
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PARTICULAR TABLE ((B)(6)) WAS MANUFACTURED IN 2004. AFTER INVESTIGATION OF THE REPORTED EVENT AND EXAMINATION OF THE RETURNED METAL STRUCTURE, IT WAS CONFIRMED THAT SEPARATION OCCURRED BETWEEN THE LOWER TRENDELENBURG ACTUATOR MOUNTING TAB AND THE COLUMN TOP PLATE. THIS WAS THE FIRST OCCURRENCE OF THIS TYPE, SO MEDICAL POSITIONING, INC. EXAMINED ALL EXISTING, IN HOUSE INVENTORY AND BEGAN MONITORING ANY REPORTS INVOLVING SIMILAR TABLES MANUFACTURED DURING THIS TIME PERIOD. MEDICAL POSITIONING, INC. HAS CONTINUED TO MONITOR THIS EVENT AND HAS FOUND NO SIMILAR OCCURRENCES IN SIMILAR TABLES MANUFACTURED BEFORE, DURING OR AFTER THIS TIME PERIOD. MEDICAL POSITIONING, INC. WAS NEVER MADE AWARE OF THE WEIGHT OF THE PT, OR IF THE WEIGHT OF THE PT EXCEEDED THE 350LB WEIGHT CAPACITY OF THE TABLE AT THE TIME IT WAS MANUFACTURED.

    Description of Event or Problem · 1

    ON (B)(6) 2009, MEDICAL POSITIONING, INC. RECEIVED A COPY OF A LAWSUIT FILED IN (B)(6) AGAINST (B)(4) AND MEDICAL POSITIONING, INC., ALLEGING THAT AN INCIDENT, WHICH TOOK PLACE ON (B)(6) 2007, CAUSED SERIOUS INJURY TO THE PLAINTIFF. THE LAWSUIT ALLEGES THAT "THE PLAINTIFF, AFTER MEDICAL TESTS HAD BEEN COMPLETED ON (B)(6) 2007, SAT UP IN THE EXAMINATION BED AND TURNED HIS LEGS TO THE SIDE OF THE BED, AS IF TO GET OFF. WHILE SITTING ON THE SIDE OF THE BED, IT SUDDENLY COLLAPSED THROWING THE PLAINTIFF VIOLENTLY ONTO THE FLOOR". THE LAWSUIT GOES ON TO STATE THAT "THE PLAINTIFF'S SHOULDER WAS SERIOUS INJURED, AND SINCE THE PLAINTIFF USES A CANE TO WALK, HE HAS BEEN REDUCED TO USING A MOTORIZED WHEELCHAIR." MEDICAL POSITIONING, INC. RECEIVED A PHONE CALL FROM THE (B)(6) MEDICAL CENTER AT (B)(6) ON (B)(6) 2007, STATING THAT AS A PT WAS GETTING OFF THE TABLE AFTER A MEDICAL PROCEDURE, THAT A WELD, WHICH CONNECTS AN ELECTRIC ACTUATOR TO THE FRAME BROKE FREE, CAUSING THE HEAD OF THE TABLE TO SUDDENLY DROP. AS IS MEDICAL POSITIONING, INC.'S STANDARD PRACTICE, AN INVESTIGATION WAS LAUNCHED. THE PERSONNEL AT THE (B)(6) MEDICAL CENTER IN (B)(6) REPORTING THE INCIDENT, STATED BY THEIR INTERVIEW OF THE PT AND THEIR PROFESSIONAL OBSERVATION THAT THE PT HAD SUSTAINED NO INJURY. BECAUSE THEIR EXAMINATION FOUND NO INJURY TO THE PT AND THE PT DID NOT COMPLAIN OF INJURY, MEDICAL POSITIONING, INC. ASSESSED THAT NO INJURY WAS SUSTAINED BY THE PT. AS A RESULT OF THIS INCIDENT, MEDICAL POSITIONING, INC. REPAIRED THE MEDICAL TABLE BY REPLACING ALL AFFECTED FRAME COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASSCAN TABLE MODEL 2184 GENERAL VASCULAR ULTRASOUND TABLE LGX MEDICAL POSITIONING, INC. 2084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other