BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1854093 · Received September 30, 2010

    Report

    Report Number
    9617766-2010-00585
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 30, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND A TRIPPED CIRCUIT BREAKER CAUSED BY A FAULTY PS1 POWER SUPPLY. REPLACED PS1. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HEARING A POPPING SOUND, SMELLING A BURNING ODOR, AND THE MONITOR WENT BLACK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1