BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL VENTILATOR CIRCUITS, HEATED-WIRE

    MDR report key: 1822399 · Received August 27, 2010

    Report

    Report Number
    1822399
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    TELEFLEX MEDICAL HUDSON RCI
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION TO VENTILATE A PATIENT, A CRACK WAS DISCOVERED ON THE ADAPTER AT THE END OF THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL VENTILATOR CIRCUITS, HEATED-WIRE SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) BZO TELEFLEX MEDICAL HUDSON RCI * 02459

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES