BEUDAMED
    FDA Adverse Event Other Summary report: N

    EIMAC-VARIAN

    MDR report key: 51396 · Received November 19, 1996

    Report

    Report Number
    51396
    Event Type
    Other
    Date Received
    November 19, 1996
    Date of Event
    November 11, 1996
    Report Date
    November 13, 1996
    Manufacturer
    ELIMAC VARIAN (SOLD TO: FISHER/MACHETT)
    Product Code
    KPW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS LYING ON THE X-RAY TABLE HAVING X-RAY TAKEN OF HER MANDIBLE. THE EXTENSION CONE WAS ON THE MACHINE. A SINGLE AP FILM HAD BEEN TAKEN. THE MACHINE WAS BEING MOVED AWAY FROM THE PT TO TAKE ANOTHER VIEW. THE MACHINE WAS ANGLED AND THE CONE FELL FROM THE MACHINE STRIKING THE PT'S HEAD. CONE INSTALLED WRONG IN 1990; SIDE MOUNT INSTEAD OF FRONT MOUNT. NO SPRING LOCK INSTALLED. LAST INSPECTION 5/29/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIMAC-VARIAN BEAM LIMITING DEVICE KPW ELIMAC VARIAN (SOLD TO: FISHER/MACHETT) S 90968 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other