BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N-550 PULSE OXIMETER

    MDR report key: 1022942 · Received March 28, 2008

    Report

    Report Number
    2936999-2008-00175
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPEAKER IS PENDING EVALUATION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A N-550 SPEAKER THAT CAME FROM A MONITOR WITH NO AUDIO. THE RESPIRATORY THERAPIST WAS NOT ABLE TO DETERMINE THE SERIAL NUMBER OF THE MONITOR, OR PROVIDE FURTHER FAILURE INFO.

    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