BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 2971986 · Received February 18, 2013

    Report

    Report Number
    2936999-2013-00098
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS VERIFIED. ISOLATED TO THE UI PCB. THE IU PCB WAS REPLACED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71323 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-65

    Patients

    Seq Age Sex Outcome Treatment
    1