BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX

    MDR report key: 236804 · Received August 16, 1999

    Report

    Report Number
    2916556-1999-00077
    Event Type
    Malfunction
    Date Received
    August 16, 1999
    Date of Event
    July 18, 1999
    Report Date
    July 18, 1999
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A RING LOCK ERROR OCCURRED THAT REQUIRED THAT RECOVERY BE INITIATED IN SVC MODE. THE PROCEDURE WAS INCORRECTLY PERFORMED BY THE FSE RESULTING IN HEAD 2 SWINGING FREELY. THERE WAS NO PT IN THE EQUIPMENT AT THE TIME OF THE EVENT. THE OPERATORS' MANUAL STATES THAT THE PT SHOULD NOT BE ON THE TABLE DURING OPERATION OF THE RING LOCKS. THERE WERE NO INJURIES TO USERS, PTS, OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX * IYY ADAC LABORATORIES VERTEX PLUS MANUAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *