BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2081007 · Received April 14, 2011

    Report

    Report Number
    9617766-2011-00903
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE PS3 POWER SUPPLY WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 8800 SYSTEM POSITIONING BUTTONS WERE NOT FUNCTIONING PROPERLY. 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