BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON DUAL HEATED LIMB CIRCUIT

    MDR report key: 1854029 · Received September 2, 2010

    Report

    Report Number
    3004365956-2010-00253
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR INVESTIGATION BUT HAS NOT BEEN RECEIVED AT THIS TIME BY MFR. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT WOULD NOT PASS LEAK TEST. THE DEFECT WAS FOUND BEFORE PT USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON DUAL HEATED LIMB CIRCUIT VENTILATOR CIRCUIT CAI TELEFLEX MEDICAL NA 02E1001993

    Patients

    Seq Age Sex Outcome Treatment
    1