BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON 80 CO-60 TELETHERAPY UNIT

    MDR report key: 4547 · Received July 23, 1992

    Report

    Report Number
    4547
    Event Type
    Malfunction
    Date Received
    July 23, 1992
    Date of Event
    May 13, 1992
    Report Date
    July 23, 1992
    Manufacturer
    THERATRONICS, INC.
    Product Code
    IWH
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 5/13/92 A SOURCE RETURN FAILURE OCCURRED ON THE THERATRON CO-60 THELETHERAPY UNITINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERATRON 80 CO-60 TELETHERAPY UNIT IWH THERATRONICS, INC. T80 #295

    Patients

    Seq Age Sex Outcome Treatment
    1 Other