BEUDAMED
    FDA Adverse Event Death Summary report: N

    N-290 PULSE OXIMETER

    MDR report key: 1380587 · Received May 8, 2009

    Report

    Report Number
    2936999-2009-00251
    Event Type
    Death
    Date Received
    May 8, 2009
    Date of Event
    January 1, 2008
    Report Date
    April 29, 2009
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE HISTORY OF THE UNIT WAS REVIEWED FOR RELEVANT RECORDS: COVIDIEN RECEIVED A SERVICE CALL ON 12/22/2008 FOR THIS N-290 SERIAL NUMBER FROM A COMPANY, THE PARENT COMPANY TO A FOREIGN FACILITY, WITH QUESTIONS ABOUT TREND DOWNLOAD, ADJUSTING THE BAUD AND PROTOCOL SETTINGS ON THE OXIMETER, AND SPEAKER; COVIDIEN PROVIDED REQUESTED INFORMATION AND A COPY OF THE SERVICE MANUAL ON 12/22/2008. COVIDIEN REQUESTED THAT THE UNIT BE RETURNED FOR FAILURE INVESTIGATION, AND THE CUSTOMER STATED IT HAS NOT BEEN RELEASED FOR RETURN TO COVIDIEN.

    Description of Event or Problem · 1

    COVIDIEN HAS RECEIVED A REPORT OF A N-290 INVOLVED IN AN INCIDENT OCCURRING DURING A UNSPECIFIED DATE IN 2008 RESULTING IN A PATIENT DEATH. THE CUSTOMER ALLEGES THAT THE UNIT DID NOT ALARM FOLLOWING THE INCIDENT. THE CUSTOMER FACILITY SEQUESTERED THE UNIT WHERE IT SAT ON A SHELF WITHOUT BEING PLUGGED INTO AC UNTIL SOMETIME IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N-290 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-290

    Patients

    Seq Age Sex Outcome Treatment
    1 Death