BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3871328 · Received April 21, 2014

    Report

    Report Number
    2936999-2014-00348
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FACTORY SERVICE CONFIRMED AND ISOLATED THE PROBLEM TO THE UNIVERSAL INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB). THE UI PCB WAS REPLACED AND THE UNIT PASSED TESTING. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT THAT THE N65 PULSE OXIMETER WAS MISSING SEGMENTS IN THE SATURATION OF PERIPHERAL OXYGEN (SPO2) PORTION OF THE DISPLAY. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241417 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1