BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIATION THERAPY RECORD AND VERIFY SYSTEM

    MDR report key: 12756 · Received April 14, 1994

    Report

    Report Number
    MW1001596
    Event Type
    Malfunction
    Date Received
    April 14, 1994
    Date of Event
    April 8, 1994
    Report Date
    April 12, 1994
    Manufacturer
    IMPAC, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    COMPUTER SYSTEM DID NOT ACKNOWLEDGE RADIATION TREATMENT GIVEN TO PT BY LINEAR ACCELERATOR. THREE OUT OF FOUR TREATED FIELDS WERE ACKNOWLEDGED AND RECORDED. SYSTEM HAS CLOCK LOG OF EVENTS RECEIVED; ACCELERATOR COMPUTER DOES NOT HAVE SUCH A SYSTEM FOR PT TREATMENTS BUT DOES FOR MACHINE FAULTS. THIS IS A REPEAT OF A SIMILAR PROBLEM REPORTED BETWEEN THE TWO DEVICES. REPORTED IMMEDIATELY TO MFR REP. MFR DID DETAILED INVESTIGATION AND IS SENDING REPORT. (SEE ALSO 1001597.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIATION THERAPY RECORD AND VERIFY SYSTEM RADIATION THERAPY RECORD AND VERIFY SYSTEM IYE IMPAC, INC. ACESS RT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other