BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT HEATED-WIRE

    MDR report key: 1881713 · Received October 6, 2010

    Report

    Report Number
    3004365956-2010-00291
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CONNECTIONS FROM THE TUBING TO THE ADAPTORS ARE VERY LOOSE AND EASILY POP OFF. CIRCUITS WILL NOT PASS THE LEAK TEST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT HEATED-WIRE NEONATAL VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02D1002121

    Patients

    Seq Age Sex Outcome Treatment
    1