BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2982123 · Received February 8, 2013

    Report

    Report Number
    1720753-2013-01575
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 8, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE PUSH HANDLE WAS REPLACED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WORKSTATION SIDE HANDLE WAS BROKEN AD FELL OFF. THERE IS NO REPORT OF PATIENT OR STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53809 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1