BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3020875 · Received March 18, 2013

    Report

    Report Number
    1720753-2013-03890
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM LEFT MONITOR WAS BLACK. THE LEFT MONITOR DISPLAYS THE LIFE FLUOROSCOPY IMAGE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112898 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1