BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N-395 PULSE OXIMETER

    MDR report key: 1012463 · Received March 11, 2008

    Report

    Report Number
    2936999-2008-00123
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS TO ORDER A SPEAKER AND DECLINED TO RETURN PRODUCT TO COVIDIEN FOR INVESTIGATION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT FROM A CLINICAL ENGINEER OF A N-395 WITH NO AUDIO FOUND DURING PREVENTIVE MAINTENANCE. ENGINEER ISOLATED THE PROBLEM TO THE SPEAKER. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N-395 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-395

    Patients

    Seq Age Sex Outcome Treatment
    1