BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW, 340 NL W/040 ADAPTOR, INT

    MDR report key: 4219118 · Received October 30, 2014

    Report

    Report Number
    1417411-2014-00071
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE REVIEW OF MANUFACTURING EVENT LOG SHOWED NO ISSUES THAT MY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. AT THE TIME OF THIS REPORT, NO SAMPLE WAS AVAILABLE FROM THE CUSTOMER, TO INVESTIGATE. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMER ON ISSUES RELATED TO HUMIDIFIER ADAPTOR COULD NOT CONNECT FOUND AT INSPECTION ON ADAPTOR PRODUCTS. THE COMPLAINT NOT CONFIRMED. ROOT CAUSE UNKNOWN.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE WING SCREW OF THE HUMIDIFIER ADAPTOR CANNOT BE CONNECTED PROPERLY TO THE OXYGEN FLOW METER. SEVERAL ATTEMPTS WERE MADE TO CONNECT TO THE FLOW METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695641 HUDSON AQUAPAK 340 SW, 340 NL W/040 ADAPTOR, INT HUMIDIFIER ADAPTOR CAF TELEFLEX 362147

    Patients

    Seq Age Sex Outcome Treatment
    1