BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAYTONA TABLE; TAVO-VL4

    MDR report key: 3831961 · Received March 7, 2014

    Report

    Report Number
    3008478792-2014-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    CONSULTRONIX S.A.
    Product Code
    HRJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3008478792-3/7/2014-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DISTRIBUTOR REPORTED THAT THE DEVICE CONTINUED TO DESCEND PAST THE ZERO POSITION WHEN THE BUTTON WAS PUSHED. THE TABLE DID NOT MOVE SPONTANEOUSLY, BUT COULD BE FORCED BELOW THE ZERO POINT WHEN THE BUTTON WAS PUSHED. UNDER ORDINARY OPERATION, ONCE THE TABLE REACHED THE ZERO POSITION ON THE COLUMN, THE TABLE SHOULD NOT RESPOND TO PUSHING THE BUTTON TO DESCEND. THE WORST CASE SCENARIO FOR RISK IS WHERE THE USER CONTINUES TO FORCE THE TABLE TO DESCEND, WHICH COULD EVENTUALLY SEVER THE ELECTRICAL CABLE / DAMAGE THE ELECTRICAL PLUG. IF THE CABLE IS SEVERED, THERE IS A RISK OF A SHOCK BEING DELIVERED TO THE PATIENT OR USER FROM THE EXPOSED CABLE. THE COMPANY'S INVESTIGATION CONCLUDED THAT THIS CONDITION COULD OCCUR UNDER THE FOLLOWING CIRCUMSTANCES WHICH WOULD MAKE THE POSSIBILITY OF SERIOUS INJURY EXTREMELY REMOTE: A GREATER THAN 15% DROP IN VOLTAGE DELIVERED TO THE UNIT; THE USER PUSHES THE BUTTON TO DRIVE THE UNIT BELOW THE ZERO POINT; THE USER DOES NOT NOTICE THAT THE TABLE CONTINUES TO DESCEND PAST THE ZERO POINT; AND THE USER DELIVERS ENOUGH FORCE (IN A SINGLE INSTANCE OR OVER TIME) TO SEVER THE CABLE OR DAMAGE THE PLUG (APPROXIMATELY 3400N) (NOTE THAT THE COLUMN'S MAXIMUM DOWNWARD FORCE IS 2500N). WHILE THE COMPANY HAS NOT HAD A REPORT OF SHOCK ASSOCIATED WITH THIS FAILURE MODE AND BELIEVES THE POTENTIAL FOR INJURY IS HIGHLY UNLIKELY, THE COMPANY IS SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION. CONSULTRONIX IS ISSUING A FIELD NOTIFICATION TO INFORM CUSTOMERS OF THIS ISSUE AND AN ALUMINUM BLOCK THAT WILL PROVIDE A MECHANICAL STOP TO PROHIBIT THE DESCENT OF THE TABLE PAST THE ZERO POINT ON THE COLUMN. THE FIELD NOTIFICATION AND ALUMINUM BLOCK WILL BE SENT TO ALL CUSTOMERS IN THE U.S. WITH POTENTIALLY AFFECTED PRODUCT.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT WHEN THE BUTTON WAS PUSHED, THE TABLE WAS ABLE TO MOVE BELOW THE ZERO POINT WHEN DESCENDING ON THE COLUMN. THERE WAS NO REPORT OF A PATIENT BEING INVOLVED IN EVENT, NOR WAS THERE ANY REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138869 DAYTONA TABLE; TAVO-VL4 TABLE, INSTRUMENT, POWERED, OPHTHALM HRJ CONSULTRONIX S.A. TAVO-VL4

    Patients

    Seq Age Sex Outcome Treatment
    1