BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRI TRANSPORT CIRCUIT

    MDR report key: 3628149 · Received February 7, 2014

    Report

    Report Number
    MW5034428
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 7, 2014
    Manufacturer
    WESTMED
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DESIGN OF THE TRANSPORT BREATHING VENT CIRCUIT ALLOWS THE CONNECTOR TO BE HOOKED UP INCORRECTLY. PT WAS PLACED AT PORTABLE VENTILATOR; PT'S SATS WERE NOTED TO DESAT TO 50S BRIEFLY PT WENT INTO RAPID AFIB WHEN SATS DROPPED, BUT RETURNED TO BASELINE WITH IMPROVED SATS AFTER BEING PLACED ON STANDARD VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80681 MRI TRANSPORT CIRCUIT PEEP VALVE, VENT CIRCUIT + PATIENT VALVE BYE WESTMED 9317 08272013401

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention