BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3915282 · Received May 27, 2014

    Report

    Report Number
    1720753-2014-04486
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE WAS NOT DUPLICATED. HOWEVER, THE FE FOUND A DEFECTIVE CONNECTOR ON THE CONTROL PCB. THE CONNECTOR WAS REPAIRED. 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 THERE WAS A FAST STOP ACTIVATED ERROR MESSAGE. THIS ERROR WILL CAUSE THE SYSTEM TO LOCK UP AND HAVE TO BE REBOOTED. THERE IS NO REPORT OR INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311426 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1