BEUDAMED
    FDA Adverse Event Summary report: N

    EQUANOX MODEL 7600 REGIONAL OXIMETRY SYSTEM

    MDR report key: 3890135 · Received May 29, 2014

    Report

    Report Number
    3890135
    Date Received
    May 29, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    NONIN MEDICAL INC
    Product Code
    DQA
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PEDIATRIC PATIENT WAS MONITORED WITH CEREBRAL/SOMATIC OXIMETRY DURING CARDIAC SURGERY. AFTER SURGERY, CHILD TAKEN TO THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU) WITH MONITORS IN PLACE. APPROXIMATELY 18 HOURS LATER, THE SENSOR ON THE PATIENT'S BACK WAS REMOVED. A PEA SIZED RED DISCOLORATION WITH A BLACK CENTER WAS NOTED. PLASTIC SURGERY AND WOUND NURSE ARRIVED TO EVALUATE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317293 EQUANOX MODEL 7600 REGIONAL OXIMETRY SYSTEM OXIMETER DQA NONIN MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR