BEUDAMED
    FDA Adverse Event Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 4133432 · Received October 1, 2014

    Report

    Report Number
    2936999-2014-00826
    Date Received
    October 1, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT WAS THAT THE UNIT DISPLAY WAS MISSING SEGMENTS. UNIT WAS POWER CYCLED MULTIPLE TIMES AND ALL SEGMENTS SHOWED ON THE DISPLAY. THE UNIT RAN FOR SEVERAL HOURS AND NO SEGMENTS WERE MISSING ON THE DISPLAY DURING THE RUN. VISUAL INSPECTION SHOWED THE DISPLAY FLEX CABLE WAS SEATED PROPERLY. NO SOLDER ISSUES WERE OBSERVED. THE UNIVERSAL INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AS A PRECAUTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO THAT THIS N65 PULS OXIMETER IS MISSING DISPLAY SEGMENTS IN THE SATURATION OF PERIPHERAL OXYGEN (SPO2) READINGS. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613405 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1