BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2960511 · Received January 24, 2013

    Report

    Report Number
    2936999-2013-00002
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN INVESTIGATION ISOLATED THE FAILURE TO THE FRONT BOARD.

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT OF A N-560 WITH A WRONG READING WHERE THE COVIDIEN SERVICE CENTER IDENTIFIED THE PROBLEM TO A SEGMENT FAILURE OF THE DISPLAY. CUSTOMER SAID THAT THIS FAILURE WAS NOT A PROBLEM ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34594 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1