BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT COLLIMATOR

    MDR report key: 3929691 · Received June 17, 2014

    Report

    Report Number
    3929691
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SUMMIT INDUSTRIES
    Product Code
    KPW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FACILITY INFORMED US (SERVICE PROVIDER) THAT THE COLLIMATOR CAME LOOSE AND FELL STRIKING A PT IN THE LEG WHILE ON THE X-RAY TABLE. WE REPAIRED COLLIMATOR FOR FURTHER USE. CONDITION OF PT IS UNK. WE (SERVICE PROVIDER), WERE CALLED IN TO COME FIX THE ISSUE WHEN WE WERE TOLD ABOUT THE COLLIMATOR STRIKING A PT. WE WERE NOT THE CURRENT SERVICE PROVIDER OF THE MEDICAL X-RAY EQUIPMENT. OUR SERVICE ENGINEER REMEMBERED THE RECALL FROM 2007 AND REPAIRED ACCORDING TO THE RECALL INSTRUCTIONS. ORIGINAL RECALL DATED 8/3/2007. THIS REPORT PROVIDED BY: (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353757 SUMMIT COLLIMATOR D800 COLLIMATOR KPW SUMMIT INDUSTRIES D800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other