BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N-550 PULSE OXIMETER

    MDR report key: 1031371 · Received April 18, 2008

    Report

    Report Number
    2936999-2008-00203
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED THAT THE UNIT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N-550 WITH NO AUDIO. THE REPORTED PROBLEM WAS FOUND PRIOR TO BEING PLACED ON A PATIENT AND NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N-550 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-550

    Patients

    Seq Age Sex Outcome Treatment
    1