BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON THERMAGARD NEBULIZER HEATER

    MDR report key: 4122189 · Received September 17, 2014

    Report

    Report Number
    1044475-2014-00268
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 27, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DEVICE HISTORY RECORD REVIEW THE UNIT DID NOT PRESENT ANY PROBLEM OR MALFUNCTION DURING THE PRODUCTION PROCESS. THE HEATER WAS TESTED PER PEGASUS (PFG SUPPLIER) SPECIFICATIONS. PEGASUS INDICATES THAT THE PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH GMP, AND FOUND TO BE IN COMPLIANCE WITH ALL APPLICABLE DRAWINGS, SPECIFICATIONS AND FUNCTIONAL STANDARDS, AS SPECIFIED IN PEGASUS PRODUCTION AND QUALITY PROCEDURES. THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE PEGASUS IS UNABLE TO DETERMINE THE CAUSE OF THE ALLEGED FAILURE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE UNIT IS OVERHEATING; THE TEMPERATURE CANNOT BE CONTROLLED AT THE TEMPERATURE KNOB. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576013 HUDSON THERMAGARD NEBULIZER HEATER NEBULIZER HEATER BZE TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1