BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED-WIRE VENTILATOR CIRCUIT

    MDR report key: 2043072 · Received February 23, 2011

    Report

    Report Number
    3004365956-2011-00070
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT MELTED WHILE THEY HAD IT SET UP ON A 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 02A1100177

    Patients

    Seq Age Sex Outcome Treatment
    1