BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTRON HDR

    MDR report key: 89528 · Received May 6, 1997

    Report

    Report Number
    1121753-1997-00014
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    October 16, 1996
    Report Date
    April 16, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDICAL CTR FILED AN MDR REPORT TO FDA AS A RESULT OF AN INCIDENT WHICH OCCURRRED ON OCTOBER 16, 1996. UPON UNEVENTFUL COMPLETION OF A PRESCRIBED TREATMENT; THEY REPORTED THAT AN ERROR CODE 187 (EC187) OCCURRED WHICH INDICATED INCOMPLETE RETRACTION OF THE MHDR SOURCE WITHIN THE CENTER OF THE RADIATION SAFE OF THE MHDR MACHINE ( THIS INDICATES THAT THE SOURCES PASSED THE REFERENCE OPTOPAIR WITHIN THE HEAD OF THE MACHINE). THE RADIATION MONITOR INDICATED THE PRESENCE OF RADIATION. THE PHYSICIST ENTERED THE ROOM USING STANDARD RADIATION PROTECTION PRACTICE ( A RADIATION MONITOR) AND DETERMINED THAT THE SOURCE WAS NOT COMPLETELY RETRACTED INTO THE CTR OF THE SAFE (THE SOURCE WAS NOT VISIBLE WITHIN THE CATHETER). USING STANDARD EMERGENCY PROCEDURES, THE HAND CRANK WAS TURNED 1/4 TURN ( WHICH INDICATES THE SOURCE WAS MOVED APPROXIMATELY 6 CM TO REACH THE RADIATION SAFE CTR), WHICH POSITIONED THE SOURCE IN THE NORMAL RETRACED POSITION WITHIN THE RADIATION SAFE. TADIATION DOSE TO THE SITE PERSONNEL (10 MR) AND THE PT (100MR) WERE ESTIMATED TO BE MINIMAL. THE INCIDENT COULD NOT BE DUPLICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other