BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTSTAT

    MDR report key: 2081929 · Received April 5, 2011

    Report

    Report Number
    1720753-2011-03260
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE (B)(6) COMPUTER WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CONNECT STAT 3000 SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTSTAT RADIOLOGICAL IMAGE PROCESSING JAA GE OEC MEDICAL SYSTEMS (SLC) CONNECTSTAT

    Patients

    Seq Age Sex Outcome Treatment
    1