BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 2501683 · Received February 28, 2012

    Report

    Report Number
    1523530-2012-00008
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MIDMARK CORP.
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EXAMINED AT THE FACILITY BY A MIDMARK REPRESENTATIVE. EXAMINATION OF THE TABLE INDICATES THE DRAWER FRONT WAS HANGING PAST ITS INTENDED POSITION AND THE TABLE WAS LOWERED ONTO IT. WHEN THE TABLE WAS LOWERED, THE DRAWER FRONT WAS PINCHED BETWEEN THE FLOOR AND THE DRAWER UNTIL THE DRAWER FRONT MOVED. WHEN THE DRAWER FRONT MOVED, THE TABLE DROPPED A FEW INCHES VERY QUICKLY. THE DRAWER FRONT IS DESIGNED TO OPEN AS A SHELF. IT IS ALSO DESIGNED SO THAT IT CAN BREAK AWAY IF A PATIENT WERE TO EXIT THE TABLE WITH THE DRAWER IN THE DOWN POSITION. THE DRAWER FRONT MUST THEN BE REPOSITIONED BY DEPRESSING THE TABS ON ITS FRONT. THIS PROCESS IS DESCRIBED IN THE PRODUCTS USER'S GUIDE. FAILURE TO CORRECTLY REPOSITION THE DRAWER FRONT CAN RESULT IN THE TYPE OF DAMAGE SEEN WITH THIS TABLE.

    Description of Event or Problem · 1

    UNIT WAS LOWERED ONTO THE DRAWER FRONT. THE BACK CONTINUED TO LOWER UNTIL IT REACHED A 3 INCH DECLINE WHEN THE DRAWER FRONT GAVE WAY CAUSING THE FRONT OF THE TABLE TO DROP. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITTER EXAMINATION TABLE FQO MIDMARK CORP. 222-015

    Patients

    Seq Age Sex Outcome Treatment
    1