BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE

    MDR report key: 5483771 · Received March 7, 2016

    Report

    Report Number
    1417411-2016-00036
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 26, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RECEIVED. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT (B)(4) (ADAPTOR,SNAP-ON FLOWMETER, FRENCH) BATCH # 2-2915742, 3-2815741, 3-2815742, 3-2915742 & 4-2815741 DURING THE MANUFACTURE OF THE MATERIAL. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO LACK SEAL OF THE ADAPTER SCREW CONNECTED TO OXYGEN SUPPLY. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED (LACK OF THE ADAPTER SCREW SEAL CONNECTED TO OXYGEN)IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE IS A LACK OF THE ADAPTOR SCREW SEAL THAT IS CONNECTED TO OXYGEN. THERE'S A DISPERSION OF OXYGEN AND IT'S NOT POSSIBLE TO CONTROL THE OXYGEN FLOW TO THE PATIENT. ANOTHER ADAPTOR WAS USED. THE PATIENT WAS CYANOTIC (HYPOXIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139654 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 544157

    Patients

    Seq Age Sex Outcome Treatment
    1