BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN AVANT MODEL 9600

    MDR report key: 2838284 · Received November 8, 2012

    Report

    Report Number
    2183646-2012-00002
    Event Type
    Death
    Date Received
    November 8, 2012
    Date of Event
    October 1, 2011
    Report Date
    November 8, 2011
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALARM LIMIT FUNCTIONALITY WAS TESTED (B)(4) 2012, TO VERIFY FUNCTIONALITY OF THE ALARM SYSTEM WITH NUMEROUS ALARM SET POINTS FOR BOTH SPO2 AND PULSE RATE ALARMS. ALL TEST POINTS PASSED NO TROUBLE FOUND WITH THE OPERATION OF THE DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INDICATING THAT AN AVANT 9600 PULSE OXIMETER SYSTEM ALLEGEDLY DID NOT ALARM WHILE MONITORING A PT AT HOME. THE FAMILY HAS REQUESTED THE DATA BE DOWNLOADED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN AVANT MODEL 9600 PULSE OXIMETER DQA NONIN MEDICAL, INC. 9600

    Patients

    Seq Age Sex Outcome Treatment
    1 Death