BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-65

    MDR report key: 3243035 · Received July 18, 2013

    Report

    Report Number
    2936999-2013-00506
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    SANMINA - SCI SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN SERVICE CENTER FOUND THAT THE DEVICE WAS MISSING SEGMENTS IN THE PULSE RATE WINDOW. THE DISPLAY CABLE WAS RE-SEATED AND SEGMENTS RETURNED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD STOP WORKING WHEN THE HEART RATE REACHES 100. COVIDIEN SERVICE CENTER FOUND THAT THE DEVICE WAS MISSING SEGMENTS IN THE PULSE RATE WINDOW. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335438 NELLCOR OXIMAX N-65 PULSE OXIMETER DQA SANMINA - SCI SYSTEMS N-65

    Patients

    Seq Age Sex Outcome Treatment
    1