BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3942043 · Received March 4, 2014

    Report

    Report Number
    2936999-2014-00208
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 29, 2014
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE FAILURE OF THE USER INTERFACE (UI) LIQUID CRYSTAL DISPLAY (LCD) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND THE UNIT PASSED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE N65 DISPLAY WAS MISSING SEGMENTS AT THE RIGHT-MOST SPO2 READING. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129643 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA COVIDIEN/FORMERLY TYCO N-65

    Patients

    Seq Age Sex Outcome Treatment
    1