BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUATHERM 111, EUROPEAN

    MDR report key: 2844740 · Received November 8, 2012

    Report

    Report Number
    3003898360-2012-00534
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 27, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE POWER LAMP IS ON BUT IS NO HEAT TO THE UNIT. THE DEVICE WAS RE-STERILIZED/RE-PROCESSED PRIOR TO THE ALLEGED EVENT. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUATHERM 111, EUROPEAN LARGE VOLUME NEBULIZER HEATER BZE TELEFLEX MEDICAL 306030164

    Patients

    Seq Age Sex Outcome Treatment
    1