BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1842287 · Received August 27, 2010

    Report

    Report Number
    1720753-2010-02864
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 27, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE ENGINEER TIGHTENED SCREWS TO RESTORE PROPER OPERATION. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S LEG EXTENSION WAS NOT UNLATCHING. NO REPORT OF PATIENT OR STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1