BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHO TABLE

    MDR report key: 2507342 · Received March 1, 2012

    Report

    Report Number
    1932056-2012-00002
    Event Type
    Other
    Date Received
    March 1, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 1, 2012
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE FACILITY'S ONE TECH STAFF WHO DISCOVERED NO DEFECT WITH THE DEVICE'S DROP SECTION. THE FACILITY'S OWN TECH STAFF CONCLUDED THAT THE EVENT WAS CAUSED BY HUMAN ERROR AND NOT BY ANY DEFECT OF THE PRODUCT.

    Description of Event or Problem · 1

    AFTER COMPLETING A PROCEDURE, THE SONOGRAPHER CLOSED THE TABLE'S DROP-SECTION, HOWEVER DID NOT FOLLOW OWNER'S MANUAL INSTRUCTIONS TO ENSURE THE DROP-SECTION IS FULLY LATCHED INTO PLACE. WHEN THE PT TURNED ONTO HER LEFT SIDE SHE PLACED HER ELBOW ON THE DROP SECTION AND APPLIED FULL BODY WEIGHT TO REPOSITION HERSELF ONTO HER LEFT SIDE. THE DROP-SECTION CAME OPEN UNEXPECTEDLY CAUSING THE PT TO DROP ONTO THE TABLE'S SURFACE. DURING THE DROP, THE PT HIT HER HEAD ON THE ULTRASOUND MACHINE CAUSING A CONTUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO TABLE ECHO TABLE DPS MEDICAL POSITIONING, INC. 2272

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other