BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRASCAN TABLE MODEL 8089

    MDR report key: 868100 · Received June 18, 2007

    Report

    Report Number
    1932056-2007-00003
    Event Type
    Other
    Date Received
    June 18, 2007
    Date of Event
    May 31, 2007
    Report Date
    June 13, 2007
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT AT HOSP. WAS BEING EXAMINED ON AN ULTRASCAN TABLE FROM MPI. AT THE TERMINATION OF THE EXAM, THE PATIENT FELL AS SHE GOT OFF OF THE TABLE. THE ULTRASOUND TECHNICIAN REPORTED THAT HER BACK WAS TURNED AND DID NOT SEE THE PATIENT FALL. THE PATIENT REPORTED THAT HER PANT LEG CAUGHT ON THE TABLE (STEM MOUNT OF CASTER) CAUSING THE FALL. THE PATIENT REPORTED THAT SHE FRACTURED A RIB IN THE FALL. FOLLOWING THE INCIDENT REPORT, THE COMPANY ATTEMPTED TO REPRODUCE THE PROBLEM. SEVERAL OBJECTS WERE USED AND THE TESTS WERE CONDUCTED IN THE PRESENCE OF FDA INVESTIGATOR RICHARD D. COLEMAN. THE COMPANY HAS BEEN UNSUCCESSFUL IN REPRODUCING A SITUATION IN WHICH A PATIENT COULD FALL IN THE MANNER DESCRIBED. THE COMPANY BELIEVES THAT THE TABLE PERFORMED PROPERLY AND THE FALL WAS NOT THE RESULT OF A DEFECT IN THE TABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other