BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2081934 · Received April 5, 2011

    Report

    Report Number
    1720753-2011-03244
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 5, 2011
    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 MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE RE-ALIGNED THE LOCKING PINS AND CLIPS IN THE LEMO CONNECTOR. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 9600 SYSTEM WOULD NOT PRODUCE AN X-RAY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1