BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4844547 · Received June 11, 2015

    Report

    Report Number
    1720753-2015-02417
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    April 28, 2015
    Report Date
    June 11, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE AC POWER CABLE ASSEMBLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO POWER UP AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380994 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900 EZ-7182-MH

    Patients

    Seq Age Sex Outcome Treatment
    1