BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA NELLCOR COMP SAT MODULE

    MDR report key: 228836 · Received June 18, 1999

    Report

    Report Number
    9610105-1999-00002
    Event Type
    Other
    Date Received
    June 18, 1999
    Date of Event
    May 18, 1999
    Report Date
    June 17, 1999
    Manufacturer
    INSTRUMENTARIUM CORP. DATEX-OHMEDA DIVISION
    Product Code
    DQA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TREND READING OF THE SPO2 (OXYGEN SATURATION MEASURED BY THE PULSE OXIMETER) SHOWED 100%, BUT BLOOD GAS ANALYSIS CALCULATED BY THE BLOOD GAS MACHINE INDICATED THAT THE ACTUAL SAO2 (ARTERIAL OXYGEN SATURATION) WAS LOWER. PT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA NELLCOR COMP SAT MODULE PULSE OXIMETER DQA INSTRUMENTARIUM CORP. DATEX-OHMEDA DIVISION M-NSAT-00-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other