BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 1182648 · Received September 24, 2008

    Report

    Report Number
    2936999-2008-00468
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 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

    INVESTIGATION HAS CONFIRMED AND ISOLATED THE PROBLEM TO THE MAIN PCB.

    Description of Event or Problem · 1

    COVIDIEN SERVICE CENTER RECEIVED A REPORT OF A N-560 WITH NO AUDIO ALARM AFTER GOING UNDER THE SET PULSE LEVEL. VISUAL ALARMS WERE PRESENT.

    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