BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N600 PULSE OXIMETER

    MDR report key: 1022141 · Received March 26, 2008

    Report

    Report Number
    2936999-2008-00170
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 28, 2008
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT IS IN TRANSIT TO THE MANUFACTURING SITE FOR FURTHER ANALYSIS OF THE OBSERVED "NO AUDIO" FAILURE.

    Description of Event or Problem · 1

    ON 03/17/2008, NEW INFORMATION WAS REC'D FROM SERVICE SITE INDICATING THAT DURING REPAIR OF THE UNIT, NO AUDIO WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N600 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN N600

    Patients

    Seq Age Sex Outcome Treatment
    1