BEUDAMED
    FDA Adverse Event Death Summary report: N

    SATURNE 1

    MDR report key: 190970 · Received October 8, 1998

    Report

    Report Number
    MW1014715
    Event Type
    Death
    Date Received
    October 8, 1998
    Date of Event
    September 2, 1998
    Report Date
    October 8, 1998
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    IYE
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR WRITES, "THIS IS A REPORT ON A MACHINE NOT MFG BY VARIAN ASSOCIATES. THIS MACHINE WAS NOT MAINTAINED EITHER BY VARIAN OR GE MEDICAL SYSTEMS ON A MAINTENANCE CONTRACT. HOWEVER, VARIAN DOES SVC GE MACHINES AT OTHER SITES, SO THIS INCIDENT WAS INVESTIGATED IN THE INTEREST OF GOOD MFG PRACTICES." DURING A STEREOTAXY TREATMENT A COLLISION OCCURRED BETWEEN THE MOVING PART OF THE MACHINE AND THE PT (CHEST OR STOMACH). PT DIED FROM CARDIAC ARREST. VARIAN WAS NOT CONTACTED BY THE CUSTOMER OR A REGULATORY AGENCY. THE SVC REP READ ABOUT THE DEATH IN A NEWSPAPER. VARIAN REC'D A FAX ON SEPT 5, 1998 REQUESTING "URGENT REVISION OF EQUIPMENT". WHEN MORE INFO WAS REQUESTED, THE SITE DID NOT MENTION AN INCIDENT, BUT INSTEAD REQUESTED A FIELD ENGINEER ON SITE TO VERBALLY TRAIN THE USER ABOUT THE SATURNE OPERATION. VARIAN/GE SVC REP REPORTS THAT A TECHNICIAN WAS NOT AVAILABLE AT THE TIME, AND WHEN A TECHNICIAN WAS AVAILABLE THE SITE PERSONNEL WERE NOT AVAILABLE FOR THE TRAINING. CUSTOMER RELATIONS SPOKE WITH THE SVC REP, AND HE REITERATED INFO IN ORIGINAL E-MAIL, AND SAID NO FURTHER NEWS HAS BEEN GATHERED ON THE INCIDENT. THE REP STATED THAT HE WOULD CONTACT THE VARIAN REPS AGAIN ON SEPT 17, 1998. CUSTOMER RELATIONS SPOKE WITH THE LEGAL DEPARTMENT, AND NO FURTHER INFO HAS BEEN REC'D THROUGH THEIR REP. LEGAL IS CONTACTING REPS BY E-MAIL FOR MORE INFO. A 30-DAY REPORT TO THE FDA HAS BEEN FILED AS THERE WAS A DEATH AND SERIOUS INJURY INVOLVED. CO'S INITIAL EVIDENCE SHOWS THAT IT WAS OPERATOR ERROR RATHER THAN MACHINE MALFUNCTION THAT CAUSED THE INJURY. CORRECTIVE ACTION: 1. IMMEDIATE, NONE. 2. PREVENTATIVE, NONE. REPLY TO CUSTOMER: AS INDICATED DURING INVESTIGATION. DATE COMPLAINT CLOSED: 09/22/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATURNE 1 MEDICAL LINEAR ACCELERATION IYE GENERAL ELECTRIC MEDICAL SYSTEMS SATURNE 1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death