BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 3902716 · Received May 7, 2014

    Report

    Report Number
    9613445-2014-00103
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BY THE HOSPITAL THAT WHEN THEY TRIED TO ROTATE THE COLLIMATOR OF A PROTEUS XR/A SYSTEM, THE COLLIMATOR SUDDENLY DETACHED AND FELL INTO THE USER HANDS. THERE WAS NO INJURY REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276081 PROTEUS XR/A KPR GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1