BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON - ODELFT LDR

    MDR report key: 78756 · Received January 8, 1997

    Report

    Report Number
    78756
    Event Type
    Malfunction
    Date Received
    January 8, 1997
    Date of Event
    July 23, 1996
    Report Date
    July 29, 1996
    Manufacturer
    NUCLETRON - ODELFT CORP.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE REMOTELY CONTROLS RADIATION SOURCES INSERTED IN A PT'S ROOM, THEY INTERRUPT THE TREATMENT, AND THE PT, RETRACTING THEM TO A SECURE AND SHIELDED HOUSING. THE DEVICE KEEPS TRACK OF THE TOTAL TREATMENT TIME THE SOURCES ARE IN THE PT, AND TERMINATES THE TREATMENT WHEN A PREDETERMINED TREATMENT TIME WHICH HAS BEEN ENTERED INTO THE DEVICE IS ATTAINED. A HARD COPY OF ALL TREATMENT INTERACTIONS IS MAINTAINED BY A PRINTER ATTACHED TO THE DEVICE. PRINTER IS THE ONLY DEVICE WHICH GIVES A HARD COPY OF ANY ERRORS WHICH OCCUR DURING THE TREATMENT, AND THE ONLY DEVICE WHICH PRINTS THE REMAINING TREATMENT TIME SHOULD A POWER OUTAGE OCCUR. THE PRINTER FAILED TWICE DURING THE TREATMENT OF THE PT. THE FIRST TIME IT WAS RESTARTED. THE SECOND TIME IT COULD NOT BE RESTARTED WITHOUT JEOPARDIZING THE REMAINING TREATMENT OF THE PT. PT TREATMENT WAS COMPLETED BY MANUALLY MONITORING THE DEVICE HOURLY. THUS IF THE DEVICE HAD EXPERIENCED AN ERROR CONDITION, NO EXACT DESCRIPTION OF THE ERROR WOULD HAVE BEEN AVAILABLE. IF THE POWER HAD FAILED, THE EXACT REMAINING TREATMENT TIME WOULD NOT HAVE BEEN AVAILABLE. THE MFR STATES THAT IT IS IMPOSSIBLE TO ATTACH A REDUNDANT PRINT DEVICE OR OTHER MEANS OF RECORDING PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON - ODELFT LDR LOW DOSE RATE AFTERLOADER JAQ NUCLETRON - ODELFT CORP. LDR3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other