BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUITY CENTRAL SATATION MONITORING SYSTEM

    MDR report key: 812600 · Received November 19, 2004

    Report

    Report Number
    3023750-2004-00016
    Event Type
    Other
    Date Received
    November 19, 2004
    Date of Event
    November 4, 2004
    Report Date
    November 18, 2004
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE CENTRAL STATION FAILED TO ALARM FOR AN ARRHYTHMIA EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL SATATION MONITORING SYSTEM CENTRAL PHYSIOLOGIC MONITORING SYSTEM DRT WELCH ALLYN PROTOCOL, INC. S/W VER.: 6.10.00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other