BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 2872493 · Received December 11, 2012

    Report

    Report Number
    2936999-2012-00643
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT'S DISPLAY WAS MISSING SEGMENTS. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1