BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3231737 · Received July 12, 2013

    Report

    Report Number
    2936999-2013-00499
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 10, 2013
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN SERVICE CTR REPLACED THE FRONT PCB, MAIN PCB, AND MAIN FRONT FLAT CABLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MALFUNCTION OF THE DISPLAY. THE (B)(4) SERVICE CENTER DETERMINED THAT THE DISPLAY WAS MISSING A HEART RATE SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322795 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1