BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3770221 · Received March 10, 2014

    Report

    Report Number
    2936999-2014-00188
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN SERVICE CENTER CONFIRMED MISSING SEGMENTS DUE TO THE UNIVERSAL INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143835 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-65

    Patients

    Seq Age Sex Outcome Treatment
    1