BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL HEATED WIRE CIRCUIT

    MDR report key: 1942030 · Received November 8, 2010

    Report

    Report Number
    3004365956-2010-00334
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 25, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING SET-UP, THE CIRCUIT DID NOT PASS THE LEAK TEST. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL HEATED WIRE CIRCUIT VENTILATOR CIRCUIT CAI TELEFLEX MEDICAL NA 02D1002889

    Patients

    Seq Age Sex Outcome Treatment
    1 NA