BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3922475 · Received June 2, 2014

    Report

    Report Number
    2936999-2014-00462
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    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

    THE SVC CTR CONFIRMED THAT THE UNIT WAS MISSING SEGMENTS. THE USER INTERFACE (UI) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND THE UNIT PASSED TESTING. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THE N65 PULSE OXIMETER HAD MISSING SEGMENTS. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320898 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-65

    Patients

    Seq Age Sex Outcome Treatment
    1