BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL CIRCUIT, DUAL HEATED LIMB

    MDR report key: 2844689 · Received November 9, 2012

    Report

    Report Number
    3004365956-2012-00318
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    September 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    TELEFLEX
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MEDWATCH. COMPLAINT ALLEGES THAT THE PRODUCT FAILED THE VENTILATOR-PRETEST AFTER PREPARING VENTILATOR FOR STAND-BY FOR THE PATIENT. COMPLAINT STATES THAT AN OCCLUSION WAS DISCOVERED IN THE PROXIMAL END OF THE INSPIRATORY LIMB THAT RESEMBLED MELTED PLASTIC. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL CIRCUIT, DUAL HEATED LIMB NEONATAL VENTILATOR CIRCUIT CAI TELEFLEX 02D1202416

    Patients

    Seq Age Sex Outcome Treatment
    1