BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MED DEVICES INC.

    MDR report key: 1454784 · Received August 21, 2009

    Report

    Report Number
    1454784
    Event Type
    Injury
    Date Received
    August 21, 2009
    Date of Event
    July 28, 2009
    Report Date
    August 6, 2009
    Manufacturer
    BIO-MED DEVICES INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING MRI WHEN HER O2 SATURATION DROPPED INTO THE 80'S AND HEART RATE IN THE 40'S. CODE BLUE WAS CALLED, AND PT WAS RESUSCITATED, AND RETURNED TO ICU WITHOUT COMPLETING THE MRI. ON THE TOP OF THE MRI VENTILATOR, THERE ARE TWO OUTLETS. THE ONE ON THE RIGHT IS FOR PRESSURE MONITORING AND THE ONE ON THE LEFT PROVIDES FLOW TO THE EXHALATION VALVE TO KEEP IT CLOSED DURING INSPIRATION. IT WAS NOT PROVIDING ENOUGH FLOW TO THE EXHALATION VALVE TO CLOSE IT DURING INHALATION. THE VALVE WAS STAYING OPEN AND MOST OF THE INSPIRATORY FLOW WAS BEING DIRECTED OUT OF THE EXHALATION VALVE. THE THERAPISTS CHANGED OUT THE CIRCUIT AND TUBING, AND IT STILL DIDN'T MAKE A DIFFERENCE. FOR THE CIRCUIT, AN IPPB CIRCUIT IS USED WITH CORRUGATED TUBING ATTACHED AS AN EXTENSION. WHEN IT WAS MALFUNCTIONING ON THE PT, THE PRESSURE MANOMETER WAS MOVING WITH EACH BREATH. BECAUSE THE MACHINE HAS NO ALARMS, YOU CAN ONLY GO BY DIRECT OBSERVATION AND MONITORING OF VITAL SIGNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MED DEVICES INC. IC-2A VENTILATOR CBK BIO-MED DEVICES INC. IC-2A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening