BEUDAMED
    FDA Adverse Event Death Summary report: N

    STATVIEW

    MDR report key: 519319 · Received April 2, 2004

    Report

    Report Number
    2124823-2004-00027
    Event Type
    Death
    Date Received
    April 2, 2004
    Date of Event
    February 19, 2004
    Report Date
    April 1, 2004
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    DRT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT STATVIEW SYSTEM DID NOT PAGE FOR NO TELEMETRY ALARM OF LEADS FAIL ALARM IN 2004 17:27:27. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATVIEW SECONDARY ALARM NOTIFICATION SYSTEM DRT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES STATVIEW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR