BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANT 2120

    MDR report key: 407952 · Received July 29, 2002

    Report

    Report Number
    2183646-2002-00002
    Event Type
    Other
    Date Received
    July 29, 2002
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE AVANT 2120 OXIMETER (CATALOG NUMBER 1217) WAS ERRONEOUSLY LABELED AS DEFIBRILLATOR PROOF AT THE TIME OF ITS RELEASE. INITIAL TESTING HAD SHOWN THE OXIMETERS NON-INVASIVE BLOOD PRESSURE (NIBP) MODULE WAS DEFIBRILLATOR PROOF AND THIS PROOF WAS THOUGHT TO EXTEND TO THE OXIMETRY FUNCTIONS AS WELL. SUBSEQUENT TESTING HAD SHOWN THE OXIMETRY WAS DEFIBRILLATOR PROOF IF UTILIZED WITH THE SENSORS PROVIDED. HOWEVER, OTHER NONIN OR OEM SENSORS WHICH MIGHT BE UTILIZED, MAY NOT HAVE SUFFICIENT DIELECTRIC STRENGTH TO PRECLUDE THE DEFIBRILLATOR CHARGE FROM PASSING TO THE OXIMETRY CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANT 2120 OXIMETRY AND BLOOD PRESSURE MONITOR DQA NONIN MEDICAL, INC. AVANT 2120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *