BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MHDR

    MDR report key: 89492 · Received May 6, 1997

    Report

    Report Number
    1121753-1997-00011
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    December 5, 1996
    Report Date
    April 16, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    JAQ
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT DURING A TREATMENT WITH UNIT, THE CONTROL CONSOLE WAS BUMPED WHICH CAUSED INTERRUPTION OF TREATMENT. THE UNIT SOURCE WAS FOUND TO BE RETRACTED INTO THE UNIT SHIELD AND NO ELEVATED RADIATION LEVELS WERE DETECTED DURING THE REQUIRED AREA SURVEY. PREVIOUSLY THE UNIT HAD FAILED TO COMPLETE INITIALIZATION AND CO PROVIDED SERVICE BY TELEPHONE. IT WAS FOUND THAT THE PRINTER LOCKING MECHANISM WAS NOT FULLY IN THE LOCKED POSITION, WHICH MADE PRINTING OF INITIALIZATION INFORMATION IMPOSSIBLE AND SUBSEQUENTLY THE INITIALIZATION PROCEDURE COULD NOT BE COMPLETED. WHEN THE LOCKING MECHANISM WAS FULLY LOCKED, THE INITIALIZATION PROCEDURE WAS COMPLETED AND RAN AS INTENDED. THE NEXT DAY, A CO SERVICE ENGINEER MADE A SITE VISIT. DURING THE SITE VISIT, THE ENGINEER FOUND THE MICRO-COMPUTER CONTROL BOARD TO BE LOOSE AND RESEATED IT, AFTER WHICH THE UNIT OPERATED NORMALLY. THE UNIT PERFORMED NORMALLY AFTER THE SITE VISIT UNTIL THE DEVICE WAS BUMPED AND THE TREATMENT WAS INTERRUPTED (THREE DWELL POSITIONS REMAINED UNTREATED). AFTER THE INTERRUPTION WAS EVALUATED, PERSONNEL DETERMINED THAT TREATMENT COULD BE SUCCESSFULLY COMPLETED. COMMUNICATION WAS REESTABLISHED AND THE REMAINING STEPS WRE SUCCESSFULLY TREATMENT. SERVICE WAS AGAIN REQUESTED AND THE ENGINEER REPLACED THE CONTROL UNIT MICRO-COMPUTER BOARD AND THE CONTROL UNIT POWER SUPPLY BOARD. AFTER REPLACEMENT OF THESE PARTS, THE UNIT OPERATED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MHDR HIGH DOSE RATE REMOTE AFTERLOADER JAQ NUCLETRON CORP. MHDR CLASSIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other