BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAN N-65

    MDR report key: 3063380 · Received April 11, 2013

    Report

    Report Number
    2936999-2013-00241
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FI VERIFIED THE REPORTED COMPLAINT OF DISPLAY HAVING MISSING SEGMENTS. ISOLATED TO THE UI BOARD. THE UI BOARD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT IS MISSING SEGMENTS ON THE BOTTOM QUARTER LED ON THE FIRST SPO2 DIGIT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155756 NELLCOR OXIMAN N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1