BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRASCAN TABLE

    MDR report key: 2018775 · Received January 31, 2011

    Report

    Report Number
    1932056-2011-00002
    Event Type
    Other
    Date Received
    January 31, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 28, 2011
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS RELEASED (B)(4) ULTRASCAN TABLES WITH AN IDENTICAL BASE FRAME DESIGN AS ONE WHICH IS THE SUBJECT OF THIS REPORT. THE COMPANY HAS RECEIVED ONLY TWO COMPLAINTS PERTAINING TO PTS TRIPPING WHEN EXITING THE TABLE. BOTH OF THE COMPLAINTS HAVE COME FROM THE SAME CUSTOMER, (B)(6). ADDITIONALLY, AS A RESULT OF THE FIRST COMPLAINT, THE COMPANY PERFORMED TESTING IN AN ATTEMPT TO RECREATE THE RESULT REPORTED BY THE CUSTOMER. THE TESTED WAS COMPLETED IN THE PRESENCE OF SEVERAL PEOPLE INCLUDING FDA (B)(6), DURING A ROUTINE LEVEL II QSIT INVESTIGATION WHICH TOOK PLACE BETWEEN (B)(6) 2007 AND (B)(6) 2007 (INVESTIGATION REMARKS ATTACHED TO THIS REPORT). THE TESTING AND RESULTS WERE INITIALLY REPORTED ON MEDWATCH FORM FDA 3500A MFR REPORT# 1932056-2007-00003. DURING THE TESTING, THE CONDITION OF A FALL COULD NOT BE RECREATED. DUE TO THE LACK OF COMPLAINTS (FROM MORE THAN ONE CUSTOMER) AND THE RESULTS OF TESTING PERFORMED AS A RESULT OF INITIAL CUSTOMER COMPLAINT, THE COMPANY STANDS BY ITS DESIGN AND WILL NOT ISSUE ANY PRODUCT CORRECTION OR RECALL NOTICE TO CUSTOMER OWNING TABLES WITH IDENTICAL DESIGN. THE COMPANY WILL HOWEVER, TO MONITOR FOR CUSTOMER COMPLAINTS AND ACTION WILL BE TAKEN AS NECESSARY IF THE ISSUE BECOMES REPETITIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, MEDICAL POSITIONING, INC BECAME AWARE OF AN INCIDENT AT (B)(6) HOSP WHERE A PT TRIPPED AND FELL WHEN EXITING A MEDICAL IMAGING PLATFORM MFG BY THE COMPANY WHEN A COPY OF MEDWATCH FORM FDA 3500A WITH UF/IMPORTER REPORTER # (B)(4) WAS RECEIVED. ACCORDING TO THE REPORT "...WHEN PTS ARE GETTING DOWN FROM THE GURNEY, THEY ARE SOMETIMES GETTING THEIR PANT LEGS CAUGHT UP ON THE METAL PIECE THAT STICKS UP FROM THE CASTERS, CAUSING THEM TO FALL...."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASCAN TABLE GENERAL ULTRASOUND TABLE LGX MEDICAL POSITIONING, INC. 8089

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other