BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3880240 · Received April 8, 2014

    Report

    Report Number
    2936999-2014-00313
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SANMINA-SCI SYSTEMS
    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

    COVIDIEN SERVICE CENTER FOUND THAT THE SATURATION OF PERIPHERAL OXYGEN (SPO2) PRINTED CIRCUIT BOARD (PCB) FAILED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THE N65 PULSE OXIMETER WAS MISSING SOME SEGMENTS IN THE DISPLAY. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211795 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA-SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1