BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1083086 · Received July 23, 2008

    Report

    Report Number
    2936999-2008-00361
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE OF NO AUDIO WAS ISOLATED TO THE MAIN PCB. THE MANUFACTURING FACILITY HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CONFIRMED FAILURE.

    Description of Event or Problem · 1

    DURING SERVICE INSPECTION FAILURE OF NO AUDIO DURING POST TONE WAS IDENTIFIED. THERE WAS NO PATIENT 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