BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO TABLE 2251

    MDR report key: 846653 · Received March 6, 2007

    Report

    Report Number
    1932056-2007-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2007
    Date of Event
    June 8, 2005
    Report Date
    February 28, 2007
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    DPS
    PMA / PMN Number
    9033862
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER OF THE MEDICAL DEVICE WAS SURPRISED TO LEARN OF A COMPLAINT APPROX ONE YEAR AFTER THE EVENT. NO CHANGE WAS MADE AT THE USER LOCATION IN THE INTERVAL AND THE EVENT DID NOT REOCCUR.

    Description of Event or Problem · 1

    MEDICAL POSITIONING, INC. WAS INFORMED ON JULY 20, 2006 BY AN ATTORNEY FOR PT THAT PT HAD SUFFERED PERSONAL INJURIES AND HELD US RESPONSIBLE IN SOME PART. MEDICAL POSITIONING HAD NEVER BEEN MADE AWARE OF THE EVENT BY THE FACILITY. WE CONTACTED THE FACILITY AND INQUIRED ABOUT THE EVENT FROM 12 MONTHS EARLIER. THE DROP SECTION GAVE WAY UNDER THE WEIGHT OF PT. PT DID NOT BREAK THE HINGE. PT BALANCED ON HER LEFT LEG AND DID NOT FALL. THE CARDIOLOGIST EXAMINED HER AND NOTED 'NO ABRASION, CONTUSIONS OR BRUISING.' PT SAID SHE HAD A HISTORY OF BACK PROBLEMS. THEY OFFERED TO SEND HER TO AN ORTHOPEDIC PHYSICIAN OR HER PHYSICAL THERAPIST. PT REFUSED AND WALKED TO THE CLINIC AREA. PT SAW HER FAMILY PHYSICIAN A DAY OR TWO LATER. NO SALE WAS MADE BY MEDICAL POSITIONING, INC. TO USING LOCATION. USING LOCATION IS AFFILIATED WITH ANOTHER LOCATION THAT PURCHASED TWO TABLES. IT IS PRESUMED THAT ONE OF THESE INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO TABLE 2251 ULTRASOUND EXAM TABLE DPS MEDICAL POSITIONING, INC. 2251 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other