BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4820897 · Received June 3, 2015

    Report

    Report Number
    1720753-2015-02315
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 3, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    PMA / PMN Number
    NA
    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 ON SITE INVESTIGATION. THE INTELLIGENT SHUTDOWN (ISD) PCB WAS EVALUATED AND RELPLACED. 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 BOOT AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357875 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900 E2-2302

    Patients

    Seq Age Sex Outcome Treatment
    1