BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA S/5 M-OSAT MODULE

    MDR report key: 403417 · Received June 28, 2002

    Report

    Report Number
    9610105-2002-00004
    Event Type
    Malfunction
    Date Received
    June 28, 2002
    Date of Event
    June 18, 2002
    Report Date
    June 28, 2002
    Manufacturer
    INSTRUMENTARIUM CORP.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATEX-OHMEDA MONITOR WAS BROUGHT IN OR DURING THE CASE. SENSOR LINES WERE RECONNECTED (SENSORS WERE NEVER MOVED ON PT). ABOUT 5 MINUTES LATER THE DOCTOR INFORMS THAT THEY HAD A PROBLEM WITH M-OSAT MODULE BECAUSE IT HAD CONTINUED READING 98% WITH A GOOD WAVEFORM BUT THE PT HAD TURNED BLUE. THEY HAD BROUGHT IN THE HP TRANSPORT OXIMETER AND IT READ 50%. THEY GOT THE PT'S COLOR TO RETURN AND THE HP TRACKED THE RISE IN SATURATION. THE CASE CONTINUED. WHEN D-0 CLINICAL ENGINEER ENTERED THE ROOM THE M-OSAT WAS READING THE SAME AS THE TRANSPORT. NO DISCREPANCIES WERE DETECTED LATER ON. LATER DURING THE CASE SEVERAL ADDITIONAL DESATURATIONS, DOWN INTO THE 70% RANGE, WERE OBSERVED AND TRACKED BY BOTH OXIMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 M-OSAT MODULE DATEX-OHMEDA S/5 OXYGEN SATURATION MODULE DQA INSTRUMENTARIUM CORP. M-OSAT *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other D-0 PULSE OXIMETER SENSOR FLEX II SENSOR.