BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 4092619 · Received August 19, 2014

    Report

    Report Number
    2936999-2014-00771
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MISSING SEGMENTS WAS CONFIRMED AND ISOLATED TO THE UNIVERSAL INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB). THE UI PCB WAS REPLACED AND THE UNIT PASSED TESTING. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THIS N65 PULSE OXIMETER IS MISSING SEGMENTS. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497010 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-65

    Patients

    Seq Age Sex Outcome Treatment
    1