BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2182110 · Received June 23, 2011

    Report

    Report Number
    2916710-2011-00072
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, MAY POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN IMRT TREATMENT, THE SITE LOST POWER AND THE CLINAC WENT DOWN. AFTER POWER OUTAGE, THE THERAPIST LOOKED AT THE BACKUP MU COUNTER, IT READ 183 (APPROX) WHICH WOULD HAVE REQUIRED ALMOST 3 FIELDS TO ACCUMULATE THAT AMOUNT OF DOSE; SO SOMEHOW THE COUNTER WAS NOT RESET. THE ACTUAL COUNT SHOULD HAVE BEEN LESS THAN 70MUS. THE DISCREPANCY WAS REPORTED THE HOSPITAL (B)(6). THE BACKUP MU COUNTER HAS BEEN MONITORED AND COMPARED TO ACTUAL MU DELIVERED SINCE THE INCIDENT; SO FAR, NO OTHER DISCREPANCIES HAVE OCCURRED. BACKUP MU COUNTER IS PROPERLY RESETTING AFTER EVERY FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H27

    Patients

    Seq Age Sex Outcome Treatment
    1