BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 601 SW,650 ML,JAPAN

    MDR report key: 5929329 · Received September 6, 2016

    Report

    Report Number
    1417411-2016-00120
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 3, 2016
    Report Date
    August 22, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOR LOT# 143156. REVIEW OF MANUFACTURING EVENT LOG SHOWED NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS SHOWED ONE NON-CONFORMANCE THAT HAS NO IMPACT ON THE QUALITY ISSUE REPORTED. NON-CONFORMING MATERIAL WAS SORTED FOR A DEFECT, RE-INSPECTED, AND FOUND TO BE ACCEPTABLE PER INTERNAL SPECIFICATION. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM CUSTOMERS ON ISSUES RELATED TO NOT SPRAYING WATER ON WATER BOTTLE PRODUCTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED AN EMPTY WATER BOTTLE WITH THE 040 HUMIDIFIER ADAPTOR ATTACHED TO THE WATER BOTTLE. ALSO, THE TRIGGER WAS REMOVED FROM THE WATER BOTTLE. THE WATER BOTTLE HAD A 1/2 INCH CRACK ON THE LEFT SIDE PANEL. DUE TO THE INDENTATION OF THE CRACK, IT WAS DETERMINED THAT THE CRACK WAS CAUSED BY AN IMPACT. NO OTHER ISSUES WERE FOUND. A FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE PERFORMED DUE TO THE CRACK IN THE WATER BOTTLE. THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE WATER COULD NOT BE PULLED OUT OF THE BOTTLE SO THE SYSTEM WAS NOT SPRAYING/MIST WATER. A NEW UNIT WAS OBTAINED WITHOUT ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE WATER COULD NOT BE PULLED OUT OF THE BOTTLE SO THE SYSTEM WAS NOT SPRAYING/MIST WATER. A NEW UNIT WAS OBTAINED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582010 HUDSON AQUAPAK 601 SW,650 ML,JAPAN RESPIRATORY GAS HUMIDIFIER BTT TELEFLEX MEDICAL 143156

    Patients

    Seq Age Sex Outcome Treatment
    1