BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT-HEATED

    MDR report key: 1820020 · Received August 25, 2010

    Report

    Report Number
    3004365956-2010-00201
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 16, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHILE THE DEVICE WAS IN USE WITH A CONCHA NEPTUNE, A 3 INCH FLAME APPEARED FROM THE INSPIRATORY LIMB DIRECTLY WHERE THE WIRES EXIT THE CIRCUIT. THE PATIENT HAD TO BE BAGGED WHILE THE CIRCUIT AND HEATER WERE REPLACED. THE INFANT WAS NOT HARMED AND REMAINED ON THE VENTILATOR AND WAS LISTED IN FINE AND STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT-HEATED NEONATAL VENTILATOR CIRCUIT DUAL LIMB BZO TELEFLEX MEDICAL NA 02F1001143

    Patients

    Seq Age Sex Outcome Treatment
    1