BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMAZ

    MDR report key: 1081576 · Received July 25, 2008

    Report

    Report Number
    2936999-2008-00366
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE UNIT ASSOCIATED WITH THIS REPORT IS IN PROGRESS. IF ADDITIONAL INFO IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING SERVICE INSPECTION OF THE UNIT FAILURE OF NO AUDIO WAS IDENTIFIED DURING POST TONE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-595 PULSE OXIMAZ PULSE OXIMETER DQA COVIDIEN/FORMERLY TYCO HEALTHCARE N-595

    Patients

    Seq Age Sex Outcome Treatment
    1