BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL HEATED WIRE CIRCUIT, DUAL LIMB

    MDR report key: 3063591 · Received April 12, 2013

    Report

    Report Number
    3004365956-2013-00109
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 17, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNK. THE ASSEMBLY PROCESS AND MFG PROCEDURE FOR PRODUCT CODE 780-09 WAS REVIEWED AND THERE WERE NO ISSUES FOUND. THE PRODUCT INSTRUCTIONS FOR USE (IFU) WERE ALSO REVIEWED AND THERE ARE SEVERAL WARNINGS LISTED TO AVOID OVERHEATING OF THE CIRCUIT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE INFANT CIRCUIT MELTED DURING MECHANICAL VENTILATION. THE HEATER WIRE WAS TOUCHING THE INSIDE OF THE CIRCUIT AT THE TIME OF THE INCIDENT. COMPLAINT STATES THAT THE INSPIRATORY AND THE EXPIRATORY LIMBS WERE NOT TOUCHING PER DEPARTMENTAL GUIDELINES. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159261 HUDSON NEONATAL HEATED WIRE CIRCUIT, DUAL LIMB NEONATAL HEATED WIRE CIRCUIT BZO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1