BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 2896628 · Received December 28, 2012

    Report

    Report Number
    2936999-2012-00675
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN VERIFIED THE FAILURE FOR A MISSING DISPLAY SEGMENT. THE FAULT WAS ISOLATED TO THE UI BOARD (USER INTERFACE BOARD). THE UI BOARD WAS REPLACED.

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED TO COVIDIEN SERVICE CENTER FOR DISPLAY SEGMENT FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1