BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V24/26 COMPONENT MONITORING SYSTEM

    MDR report key: 486661 · Received October 2, 2003

    Report

    Report Number
    1218950-2003-00182
    Event Type
    Injury
    Date Received
    October 2, 2003
    Date of Event
    May 27, 2003
    Report Date
    May 28, 2003
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A USER WAS UNABLE TO OBTAIN A PT'S ECG SIGNAL ON THE BEDSIDE MONITOR. A SECOND PT CABLE AND ECG MODULE WERE SWAPPED IN, BUT THE FLATLINE REMAINED. THE USER MONITORED THE PT WITH THE "CRASH CART" WHILE THE PT WAS BEING RESUSCITATED. THE PT WAS SUCCESSFULLY REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V24/26 COMPONENT MONITORING SYSTEM BEDSIDE MONITOR DRT AGILENT TECHNOLOGIES, INC. M1205A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention