BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTION HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM

    MDR report key: 19440 · Received February 6, 1995

    Report

    Report Number
    MW1005027
    Event Type
    Malfunction
    Date Received
    February 6, 1995
    Report Date
    February 3, 1995
    Manufacturer
    NUCLETRON CORP.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MFR COMES TO THE HOSP EVERY THREE MONTHS TO REPLACE THE SOURCE AND DO PREVENTIVE MAINTENANCE. DURING THE LAST VISIT A DEFECTIVE TIMER CRYSTAL WAS INSTALLED. THE SERVICEMAN NEVER CHECKED THE ACCURACY OF THE TIMER, WHICH WAS FOUND TO BE OFF BY ONE SECOND PER MINUTE BY THE HOSP DURING QC CHECKS PRIOR TO PT TREATMENT. THE RPTR IS CONCERNED THAT THE SERVICEMAN ASSUMED THE TIMER TO BE ACCURATE AND DID NOT CHECK IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTION HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM JAQ NUCLETRON CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *