BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN CEREBRAL OXIMETRY SYSTEM

    MDR report key: 2394709 · Received December 28, 2011

    Report

    Report Number
    MW5023621
    Event Type
    Injury
    Date Received
    December 28, 2011
    Date of Event
    December 14, 2011
    Report Date
    December 19, 2011
    Manufacturer
    NONIN MEDICAL INC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANESTHETIST USING NONIN CEREBRAL OXIMETRY DURING RIGHT CAROTID ENDARTERECTOMY. SENSORS WORKED INITIALLY BUT AFTER RIGHT CAROTID ARTERY CLAMPED THE RIGHT SENSOR READ "- - -." ALL ELECTRIC CONNECTIONS DOUBLE CHECKED. LEFT SIDE READ NORMAL. RIGHT SENSOR LIFTED BY ANESTHETIST AND ONLY ONE OF THE FOUR LEDS WAS FLASHING RED. NEW SENSOR PLACED AND READINGS RETURNED TO MATCH LEFT SIDE. PRIOR TO REPLACING SENSOR THE CAROTID WAS SHUNTED AND THERE WAS NO CHANGE IN RIGHT CEREBRAL OZ. CAUSE FELT TO BE DEFECTIVE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN CEREBRAL OXIMETRY SYSTEM CEREBRAL OXIMETRY DQA NONIN MEDICAL INC 7600 23707 (SENSOR)

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention