BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS

    MDR report key: 304528 · Received November 8, 2000

    Report

    Report Number
    MW1020382
    Event Type
    Malfunction
    Date Received
    November 8, 2000
    Date of Event
    November 5, 2000
    Report Date
    November 8, 2000
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL DIV.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH DIAGNOSIS OF RESPIRATORY DISTRESS WAS PLACED ON A SIEMENS BEDSIDE MONITOR. THIS REPORT DEALS SPECIFICALLY WITH THE PULSE OXIMETRY FUNCTION OF THE SIEMENS MONITOR. THE NURSE CARING FOR THIS PT CONFIRMED THAT THE ALARM PARAMETERS WERE SET AND THAT THE ALARMS WERE TURNED ON. WHILE THE NURSE WAS IN THE ROOM THAT PT'S OXYGEN SATURATION LEVEL BEGAN TO DROP. THE LEVEL DID DROP BELOW THE SET PARAMETERS BUT NO ALARM SOUNDED. AFTER ATTENDING TO THE PT, THE NURSE SHUT THE UNIT OFF AND TURNED IT BACK ON AGAIN. ONCE THE ALARMS AND ALARM PARAMETERS WERE RESET THE ALARM FUNCTIONED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BEDSIDE MONITOR DRT SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL DIV. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR