BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED WIRE CIRCUIT

    MDR report key: 1842720 · Received August 27, 2010

    Report

    Report Number
    3004365956-2010-00210
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    June 24, 2010
    Report Date
    August 18, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: OTHER - DEVICE HISTORY RECORD REVIEW. VISUAL EXAMINATION OF PHOTOS. RESULTS: OTHER - DEVICE HISTORY RECORD REVIEW WAS DONE ON A SUBSTITUTED LOT NUMBER (02G1002457). NO ISSUES RELATED TO THE REPORTED COMPLAINT DESCRIPTION WERE FOUND. VISUAL EXAMINATION SHOWS THE OLD WYE CONNECTOR. CONCLUSIONS: OTHER - (B)(4) WAS OPENED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE WAS A CRACK AT THE MACHINE END OF THE INSPIRATORY LIMB. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HEATED WIRE CIRCUIT VENTILATOR CIRCUIT CAI TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1