BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 2192618 · Received August 1, 2011

    Report

    Report Number
    MW5021595
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    HUDSON RCI
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY WAS TESTING A VENTILATOR CIRCUIT AND THE TUBING BLEW OFF THE VENTILATOR AND SPLIT THE TUBING IN TWO PLACES. THIS WAS NOT CONNECTED TO A PT, BUT RATHER THE THERAPIST WAS TESTING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI VENTILATOR CIRCUIT BZO HUDSON RCI H8807802409

    Patients

    Seq Age Sex Outcome Treatment
    1