BEUDAMED
    FDA Adverse Event Summary report: N

    HUDSON HEATED DUAL LIMB CIRCUIT-NEONATAL

    MDR report key: 1981775 · Received January 24, 2011

    Report

    Report Number
    3004365956-2011-00044
    Date Received
    January 24, 2011
    Date of Event
    March 25, 2010
    Report Date
    January 13, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT. INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MEDWATCH REPORT FROM FDA. THE EVENT IS REPORTED AS: WHILE A PT WAS ON VENTILATOR SUPPORT THE VENTILATOR ALARMED. A RESPIRATORY TECH RESPONDED IMMEDIATELY AND DISCOVERED A CRACK IN A NEWLY APPLIED CIRCUIT. THE CRACK APPEARED ON THE TUBING BETWEEN THE HUMIDIFIER AND THE VENTILATOR. MANUAL VENTILATION SUPPORT WAS PROVIDED UNTIL CIRCUIT TUBING COULD BE CHANGED OUT. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK