BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2040977 · Received March 23, 2011

    Report

    Report Number
    9617766-2011-00675
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND ADJUSTED THE IMAGE INTENSIFIER POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM HAD IMAGE QUALITY PROBLEMS AND IS DOWN. 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