BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO TABLE

    MDR report key: 2369811 · Received December 8, 2011

    Report

    Report Number
    1932056-2011-00007
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    September 23, 2011
    Report Date
    October 19, 2011
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED THROUGH OUR INVESTIGATION THAT THE LATCHES WHICH HOLD THE DROP-SECTION CLOSED HAD COME OUT OF ADJUSTMENT, THE PROBLEM WITH THE CUSTOMER'S DROP-SECTION LATCHES WAS PROMPTLY REMEDIED BY ADJUSTING THE LATCHES. WITH AN INSTALLED PRODUCT BASE OF OVER 5000 UNITS, A SIMILAR SITUATION HAS NEVER BEEN REPORTED TO THE CO. THE USER MANUAL SECTION FOR PREVENTIVE MAINTENANCE INSTRUCTS THE CUSTOMER TO INSPECT THE DROP SECTION LATCH MECHANISM ANNUALLY AND ADJUST IF NECESSARY. THE COMPANY WILL CONTINUE TO MONITOR CUSTOMER COMPLAINTS FOR OUT OF ADJUSTMENT DROP-SECTION LATCHES TO SEE IF ANY CORRECTIVE ACTION IS NECESSARY.

    Description of Event or Problem · 1

    THE DROP-SECTION ON AN ECHO TABLE MODEL 2272 WILL FALL OPEN WHEN PT WEIGHT IS APPLIED. NO INJURY OR DEATH WAS REPORTED AS A RESULT OF THE COMPLAINT FILED WITH MEDICAL POSITIONING, INC. BUT IT IS FORESEEABLE THAT IF PT WEIGHT IS APPLIED TO THE DROP-SECTION DURING PT INGRESS/EGRESS, IT MAY LEAD TO PT FALL WHICH COULD CAUSE A SERIOUS INJURY SUCH AS A BREAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other