BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 2872485 · Received December 11, 2012

    Report

    Report Number
    2936999-2012-00647
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE FAILURE WAS ISOLATED TO THE UI BOARD. THE UI BOARD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT WAS MISSING DISPLAY SEGMENTS. THERE WAS NO PT INVOLVEMENT. PROBLEM WAS FOUND DURING PREVENTIVE MAINTENANCE.

    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