BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED WIRE VENTILATOR CIRCUIT

    MDR report key: 1933872 · Received December 7, 2010

    Report

    Report Number
    3004365956-2010-00353
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR FOR EVAL, 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: THE CIRCUIT MELTED WHILE ON THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HEATED WIRE VENTILATOR CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02D1001096

    Patients

    Seq Age Sex Outcome Treatment
    1