BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2770152 · Received October 1, 2012

    Report

    Report Number
    2936999-2012-00491
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 10, 2012
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN INVESTIGATIO CONFIRMED A LOW VOLUME OF THE UNIT. THE UNIT HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION WHERE THE FAILED ASSEMBLY WILL BE DETERMINED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N-560 WHERE THE SPEAKER AUDIO WAS TOO LOW. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1