BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED-WIRE VENTILATOR CIRCUIT W/LIMB

    MDR report key: 2151097 · Received June 20, 2011

    Report

    Report Number
    3004365956-2011-00249
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    June 3, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CIRCUIT LEAKED DURING TESTING. THE CIRCUITS WERE BEING TESTED ON AN ACHIEVA VENT WHEN THE ALLEGED FAILURE OCCURRED. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA