BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3874633 · Received April 24, 2014

    Report

    Report Number
    1720753-2014-03644
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE WAS EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. THE PS1 POWER SUPPLY WAS ALSO EVALUATED AND REPLACED AS PART OF THE SERVICE EVENT. 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 RE- BOOT TO A USABLE STATE 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
    248179 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 8800

    Patients

    Seq Age Sex Outcome Treatment
    1