BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2030194 · Received March 7, 2011

    Report

    Report Number
    1720753-2011-01977
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 7, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SVC REP PERFORMED AN ON-SITE INVESTIGATION. THE CINE DRIVE AND BACK PLANE WERE REPLACED. THE SYS WAS TESTED AND IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CINE DISK DRIVE WAS NOT BEING RECOGNIZED BY THE 9800 SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1