BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 1031369 · Received April 18, 2008

    Report

    Report Number
    2936999-2008-00204
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN INVESTIGATION CONFIRMED THE REPORTED PROBLEM OF NO ALARM TONE AND ISOLATED AN INTERMITTENT ALARM TO THE MAIN PCB.

    Description of Event or Problem · 1

    COVIDIEN SERVICE CENTER RECEIVED A DEVICE WITH A REPORT OF NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1