BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3060822 · Received April 5, 2013

    Report

    Report Number
    1720753-2013-04682
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 5, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE COLLIMATOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COLLIMATOR STUCK ERROR. THE FIELD ENGINEER NOTED THAT THE COLLIMATOR WAS CLOSED ALL THE WAY DOWN. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141899 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1