BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1173044 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26054
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED REPLACED THE POWER SUPPLY FUSE. THE SYSTEM IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERLOCK ERROR MESSAGE DISPLAYED ON THE SYSTEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1