BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 798757 · Received January 19, 2006

    Report

    Report Number
    9617251-2006-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2006
    Date of Event
    November 11, 2005
    Report Date
    January 19, 2006
    Manufacturer
    SEDECAL S.A.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - AFTER REPAIRING THE UNIT AND UPGRADING TWO CIRCUIT BOARDS WITH NEWER VERSIONS, THE PROBLEM COULD NOT BE DUPLICATED. THE ROOT CAUSE OF THE ORIGINAL MALFUNCTION IS STILL UNDER INVESTIGATION, BUT MAY NEVER BE KNOWN. THIS PROBLEM HAS NEVER BEEN OBSERVED BEFORE.

    Description of Event or Problem · 1

    THE TECHNOLOGIST SAYS THAT THE SYSTEM BECAME LOCKED UP WHILE HE WAS USING IT. HE WAS ATTEMPTING TO DRIVE THE TUBE SUPPORT ARM DOWN WHILE IN THE CHEST POSITION. THE VERTICAL DRIVE CONTINUED DRIVING DOWN EVEN THOUGH HE HAD RELEASED THE CONTROL SWITCH. IT DROVE DOWN ALL THE WAY TO THE BOTTOM AND CONTINUED DRIVING UNTIL THE MOTOR BLEW A FUSE. THE SUPPORT ARE ACTUALLY BEGAN TO MOVE UP A LITTLE BEFORE IT STOPPED OPERATING. THERE WAS AN ERROR MESSAGE R134 ON THE DISPLAY. HE TRIED RESETTING THE MACHINE, BUT IT DID NOT CLEAR THE PROBLEM. THERE WAS NOTHING ON EITHER DISPLAY (THE LCD OR LEDS OF THE CONTROL AT THE TUBE HEAD). NO MOVEMENTS WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDECAL DIAGNOSTIC X-RAY SYSTEM MQB SEDECAL S.A. URS LP *

    Patients

    Seq Age Sex Outcome Treatment
    1 *