BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT HEATED-WIRE CIRCUIT DUAL LIMB

    MDR report key: 2972172 · Received February 15, 2013

    Report

    Report Number
    3004365956-2013-00049
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. THE DEVICE HISTORY RECORD (DHR) REVIEWED WAS CONDUCTED ON THE REPORTED LOT NUMBER. NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS ISSUE. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT NUMBER IN QUESTION.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE COMPLAINT ALLEGES THAT THE CIRCUIT FAILED THE LEAK TEST. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69434 HUDSON ADULT HEATED-WIRE CIRCUIT DUAL LIMB HEATED-WIRE VENTILATOR CIRCUIT CAI TELEFLEX MEDICAL 02M1201225

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR| HUMIDIFIER