BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE

    MDR report key: 1671382 · Received April 26, 2010

    Report

    Report Number
    3003793371-2010-00004
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K010975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE CUSTOMER TO FIND OUT ADDITIONAL INFO REGARDING THE ALLEGED MISADMINISTRATION. THE CUSTOMER CONFIRMED THAT A MISADMINISTRATION TO A PT HAD OCCURRED. IT WAS REPORTED THAT FOLLOWING THE HOSPITAL'S INTERNAL INVESTIGATION, THE MISADMINISTRATION WAS DUE TO A USER ERROR DURING THE NORMALIZATION OF THE TREATMENT PLAN. THE CUSTOMER CONFIRMED AGAIN THAT NO PRODUCT MALFUNCTION HAD OCCURRED. EVEN THOUGH, NO ADDITIONAL INFO COULD BE GATHERED FROM THE CUSTOMER, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THERE'S NOT ENOUGH INFO THAT A SERIOUS INJURY HAS NOT OCCURRED. NO FURTHER FOLLOW UP IS ANTICIPATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT HAD BEEN MIS-ADMINISTERED DURING RADIATION TREATMENT. THE CUSTOMER ONLY REPORTED THAT THE PLAN HAD NOT BEEN PROPERLY NORMALIZED. THE CUSTOMER ALSO ALLEGES THAT NO SOFTWARE FAILURE OCCURRED. NO SERIOUS INJURY TO THE PT WAS REPORTED, ONLY AN ALLEGATION THAT THE PT HAD BEEN MISTREATED. ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL INFO, BUT NO FURTHER DETAILS ARE UNK TO VARIAN AT THIS TIME. THE CUSTOMER DID REPORT THAT THEIR FACILITY IS REPORTING TO THEIR LOCAL STATE HEALTH AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1