BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9400

    MDR report key: 2152567 · Received June 22, 2011

    Report

    Report Number
    1720753-2011-08419
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 22, 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

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CABLE ASSEMBLY NEEDS TO BE REPLACED. NO ADDITIONAL SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HAD NO POWER TO THE IMAGE CART WHILE IT WAS TURNED ON DURING A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9400 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9400

    Patients

    Seq Age Sex Outcome Treatment
    1