BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3850851 · Received February 11, 2014

    Report

    Report Number
    2936999-2014-00103
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    SANMINA-SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VERIFIED THE CUSTOMER COMPLAINT THAT THE UNIT DISPLAY WAS MISSING SEGMENTS. ISOLATED PROBLEM TO THE UNIVERSAL INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB). THE UI PCB WAS REPLACED AND THE UNIT PASSED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE N65 MONITOR IS MISSING SEGMENTS IN THE LOWER PORTION OF THE PULSE RATE DISPLAY. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91060 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1