BEUDAMED
    FDA Adverse Event Summary report: N

    DATEX-OHMEDA SATSENSOR

    MDR report key: 294633 · Received September 8, 2000

    Report

    Report Number
    9610105-2000-00003
    Date Received
    September 8, 2000
    Date of Event
    July 31, 2000
    Report Date
    August 28, 2000
    Manufacturer
    INSTRUMENTARIUM CORP. / DATEX-OHMEDA DIVISION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBE READING 100% WHEN CLINICALLY THE PT WAS 80%. PT WAS BEING VENTILATED ON A SIEMENS 300A VENTILATOR, ON 45% OXYGEN, ON PRESSURE SUPPORT AND CONTINUOUS POSITIVE AIRWAY PRESSURE, AND WAS BREATHING SPONTANEOUSLY. AT THIS STAGE PT'S SPO2 WAS HIGH 90'S/100%. THE CONSULTANT WAS CONTINUING A VERY SLOW WEANING PROCESS GRADUALLY REDUCING THE OXYGEN TO 21%. THE SPO2 WAS STILL MEASURING 100%. THIS WAS BEING MEASURED ON A PLETH2 AND THERE WAS A GOOD WAVEFORM WITH ALL THE SIGNS INDICATING A GOOD PICK UP. THE PT THEN STARTED TO GO OFF, RESPIRATION INCREASING TO 44, BECOMING TACHYCARDIC, SWEATY AND CYANOSED. AS A RESULT THE PT HAD TO BE FULLY VENTILATED AGAIN AND WAS UNSTABLE FOR 24 HOURS. PT IS NOW OFF VENTILATORY SUPPORT (08/11/2000) AND IS BREATHING VIA A TRACHEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA SATSENSOR PULSEOXIMETER FINGER SATSENSOR DQA INSTRUMENTARIUM CORP. / DATEX-OHMEDA DIVISION SAS-F..00 140499

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other SIEMENS 300A (UNK TO UNK (CONTIN)).