BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 3727319 · Received January 29, 2014

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    Report

    Report Number
    2936999-2014-00060
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THIS UNIT HAS NO AUDIO. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63649 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DPZ COVIDIEN, FORMERLY TYCO HEALTHCARE N595

    Patients

    Seq Age Sex Outcome Treatment
    1