BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXIMAX NEONATAL/ADULT OXYGEN SENSOR

    MDR report key: 3962484 · Received July 11, 2014

    Report

    Report Number
    2936999-2014-00644
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    PMA / PMN Number
    K052186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS IN THE PROCESS OF OBTAINING FURTHER INFORMATION SURROUNDING THE CIRCUMSTANCES OF THIS REPORT. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. LOT NUMBER WAS UNKNOWN THEREFORE DEVICE MANUFACTURING DATE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT A NEONATE PATIENT WAS BURNED ON HIS/HER HAND BY HIGH TEMPERATURE OF THE LED LIGHTS. THE SURGEON DISCARDED THE SENSOR, SO THIS SAMPLE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405901 OXIMAX NEONATAL/ADULT OXYGEN SENSOR OXIMAX MAXN OXYGEN SENSOR DQA COVIDIEN MAXNI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other