BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N600 PULSE OXIMETER

    MDR report key: 1022944 · Received March 28, 2008

    Report

    Report Number
    2936999-2008-00173
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 27, 2008
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEADQUARTERS
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNIT WAS REQUESTED BACK FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT THAT THE PRIMARY SPEAKER ON THE DEVICE DID NOT PROVIDE AN AUDIBLE TONE. THE CALLER CONFIRMED THAT THE SECONDARY SPEAKER DID FUNCTION AS INTENDED AND PROVIDED AN AUDIBLE TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N600 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN/ FORMERLY TYCO HEADQUARTERS N600

    Patients

    Seq Age Sex Outcome Treatment
    1