BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN AVANT MODEL 9600

    MDR report key: 2902967 · Received January 4, 2013

    Report

    Report Number
    2183646-2012-00003
    Event Type
    Death
    Date Received
    January 4, 2013
    Date of Event
    January 17, 2010
    Report Date
    December 31, 2012
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THEY WERE UNSURE IF THE DEVICE WAS CONNECTED TO THE VENTILATOR DEPENDANT PT, AND THE DEVICE HAS NOT BEEN RETURNED TO US FOR EVAL EVEN THOUGH IT WAS REQUESTED TO BE RETURNED TO RECOVER DATA FROM THE DEVICE DURING THE INITIAL REPORT OF THE COMPLAINT.

    Description of Event or Problem · 1

    PER DISTRIBUTOR CUSTOMER REPORT, "THE DEVICE DID NOT ALARM WHEN THERE WAS ALLEGEDLY DESATURATION ON THE VENT THE PT WAS ON, CAUSING NO ONE TO BE ALERTED AND THE PT TO EXPIRE. PASSED AWAY ON (B)(6) 2010 AROUND 6:00PM. THEY ARE ASKING WE PULL THE DOWNLOAD TO LOOK FOR THIS DESATURATION, THAT SHOULD HAVE BEEN CAUSED BY THE INFANT HAVING A BLOCKAGE IN THEIR TRAQUE [SIC]. THE CHILD WAS BORN (B)(6) AND HAD MULTIPLE HEALTH ISSUES TO BEGIN WITH SUCH AS BEING PREMATURELY WITH ANOXIC BRAIN INJURY LEAVING THEM IN A VEGETATIVE STATE, WITH A TRAQUE [SIC], SEVERAL HEART DEFECTS AND ABNORMALITIES." HOW LONG WAS THE DEVICE IN USE THIS SESSION? "NOT SURE - THEY ARE NOT SURE IF IT WAS EVEN ON THE PT." WHAT WERE THE DEVICE SETTINGS? "HIGH O2-OFF, LOW O2-88% (LAST CHECKED ON (B)(6) 2010).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5197 NONIN AVANT MODEL 9600 PULSE OXIMETER DQA NONIN MEDICAL, INC. 9600

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Death