BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1190697 · Received October 3, 2008

    Report

    Report Number
    2936999-2008-00495
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 30, 2008
    Manufacturer
    COVIDIEN FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNIT WAS SENT TO MANUFACTURING FOR FAILURE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COVIDIEN FORMERLY TYCO HEALTHCARE INITIALLY RECEIVED THIS UNIT FOR SERVICE, DUE TO DROPPED/ DAMAGED DURING SERVICE ON 9/30/08, THE UNIT WAS DISCOVERED TO NOT PROVIDED AN AUDIO TONE. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1