BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUETTE ELECTRONICS

    MDR report key: 298615 · Received September 25, 2000

    Report

    Report Number
    298615
    Event Type
    Injury
    Date Received
    September 25, 2000
    Date of Event
    April 11, 2000
    Report Date
    September 22, 2000
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    DPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED ANESTHESIA FOR A SURGICAL PROCEDURE, A VAGINAL HYSTERECTOMY. PT WAS EXTUBATED IN THE OPERATING ROOM, FOLLOWED COMMANDS, BREATHING SPONTANEOUSLY AND MOVING ALL EXTREMITIES. THE SURGERY WAS UNEVENTFUL. PT WAS TRANSPORTED TO THE POST ANESTHESIA CARE UNIT. WHEN PT WAS PUT ON THE POST-SURGICAL MONITORING DEVICE, THE NURSE ASSIGNED FAILED TO TURN ON THE ALARM, RESULTING IN PACU STAFF UNABLE TO DETECT WHEN PT'S BREATHING HAD BECOME ABNORMAL. THE POST-SURGICAL MONITORING DEVICE HAS A THREE STEP PROCESS TO ACTIVATE THE ALARM. NURSE FAILED TO COMPLETE STEP THREE OF THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE ELECTRONICS TRAMSCOPE MONITOR DPS MARQUETTE ELECTRONICS, INC. EAGLE VERSION *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening