BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAPAK 640 SW, 650 ML W/040 ADAPTOR

    MDR report key: 2062539 · Received March 21, 2011

    Report

    Report Number
    1417411-2011-00040
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT AVAILABLE FOR EVAL BY MFR. IF ADDITIONAL INFO OR SAMPLE IS RECEIVED, A F/U REPORT WILL BE SENT. EVAL CODES: METHOD: DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED. RESULTS: DHR REVIEW SHOWED THERE WERE NO ISSUES OR DISCREPANCIES FOUND THAT COULD RELATE TO THIS COMPLAINT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED DUE TO LACK OF SAMPLE. CONCLUSION: NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: OXYGEN LEAKS WERE DETECTED DURING THE CONNECTION. THERE WAS WHISTLING AT THE LEAK LEVEL. THERE WAS A VISIBLE HORIZONTAL CRACK AT THE SLEEVE AREA AS WELL. THE AQUAPAK WAS UNUSABLE. THERE WAS NO CLINICAL CONSEQUENCE FOR THE PT AND ANOTHER DEVICE WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAPAK 640 SW, 650 ML W/040 ADAPTOR AQUAPAK HUMIDIFIER CAF TELEFLEX MEDICAL NA 122106

    Patients

    Seq Age Sex Outcome Treatment
    1