BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3172116 · Received June 11, 2013

    Report

    Report Number
    1720753-2013-06941
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SYSTEM WAS IN LATERAL POSITION, THE MONITOR INTERMITTENTLY WOULD GO BLANK AND A COMMUNICATION ERROR MESSAGE WOULD BE DISPLAYED. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264446 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1