BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAX 40E

    MDR report key: 4350569 · Received December 16, 2014

    Report

    Report Number
    2126677-2014-00025
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 17, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K88493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TECHNOLOGIST WAS REPOSITIONING THE TUBE OF A COMPAX 40E X-RAY SYSTEM AFTER DOING AN AP UPRIGHT VIEW, THE COLLIMATOR DETACHED AND HIT HER ON THE WRIST. A PT WAS ON THE TABLE AT THE TIME BUT WAS NOT INJURED. THERE WAS NO INJURY TO THE TECHNOLOGIST AS A RESULT OF THE COLLIMATOR IMPACTING THE WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823827 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC XRA003

    Patients

    Seq Age Sex Outcome Treatment
    1