BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3831912 · Received March 6, 2014

    Report

    Report Number
    2936999-2014-00214
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SANMINA-SCO SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION CONFIRMED THAT THE UNIVERSAL INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB) WAS FAULTY. THE UI PCB WAS REPLACED AND THE UNIT PASSED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE N65 DISPLAY WAS MISSING SEGMENTS WHEN THE DEVICE WAS TURNED ON. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135946 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCO SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1