BEUDAMED
    FDA Adverse Event Death Summary report: N

    N-290 PULSE OXIMETER

    MDR report key: 1690120 · Received May 12, 2010

    Report

    Report Number
    2936999-2010-00776
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 27, 2010
    Manufacturer
    COVIDIEN - FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K972837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNING OF THE DEVICE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N-290 INVOLVED IN AN INCIDENT OCCURRING (B) (6) 2010 RESULTING IN A PT DEATH. THE CUSTOMER ALLEGES THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE WHEN THE INCIDENT OCCURRED. THE CUSTOMER DOES NOT KNOW WHAT READING HAD SHOWN AT THE TIME OF THE EVENT.

    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 22 YR Death