BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT, NEONATAL, DUAL HTD LUMB W/18 IN

    MDR report key: 2241275 · Received August 19, 2011

    Report

    Report Number
    3004365956-2011-00325
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Report Date
    August 12, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CIRCUITS FAILED THE LEAK TEST. UNIT WAS BEING TESTED ON A VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CIRCUIT, NEONATAL, DUAL HTD LUMB W/18 IN NEONATAL CIRCUIT CAI TELEFLEX MEDICAL 02D1100241

    Patients

    Seq Age Sex Outcome Treatment
    1