BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, SPEAKER

    MDR report key: 1001212 · Received February 22, 2008

    Report

    Report Number
    2936999-2008-00087
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 5, 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

    THE SPEAKER ASSOCIATED TO THIS REPORT WILL NOT BE RETURNED FOR EVAL. THE CUSTOMER ELECTED TO RETURN THE DEVICE FOR EVAL.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE SPEAKER DID NOT PROVIDE AN AUDIO TONE. THIS SPEAKER WAS BEING USED TO ISOLATE A PREVIOUS REPORT OF NO AUDIO. THE SPEAKER ASSOCIATED TO THIS REPORT ALSO FAILED TO PROVIDE AN AUDIO TONE WHEN INSTALLED INTO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSY, SPEAKER SPEAKER ASSEMBLY DQA NELLCOR PURITAN BENNETT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA