BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N600 PULSE OXIMETER

    MDR report key: 1002150 · Received February 25, 2008

    Report

    Report Number
    2936999-2008-00094
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 21, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER HAS DECLINED RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RETURNED FOR INVESTIGATION, RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N600 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA