BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRIDA TELEMETRY

    MDR report key: 261627 · Received January 24, 2000

    Report

    Report Number
    261627
    Event Type
    Death
    Date Received
    January 24, 2000
    Date of Event
    December 31, 1999
    Report Date
    January 24, 2000
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED FOR IV HYDRATION, JAUNDICE, GALL BLADDER EVAL. TWO DAYS LATER PT HAD A CHOLECYSTECTOMY. TWO DAYS POST-OP AT 1303 CENTRAL TELEMONITORING NOTED OFF DUE TO NO BATTERY CHARGE. AT 1328, BATTERY REPLACED. EKG READS ASYSTOLE. PT CODED. INTUBATED. ON VENTILATOR. 4 DAYS POST OP DETERMINED "BRAIN DEAD." VENTILATOR DISCONNECTED. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRIDA TELEMETRY TELEMETRY MONITOR DEVICE DSI AGILENT TECHNOLOGIES M2601A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death EPIDURAL FENTANYL INFUSION PER CADD PRISM PCS.