BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2232145 · Received September 1, 2011

    Report

    Report Number
    9611451-2011-00540
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WIL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT236 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. THE RETURNED DEVICE HAD BEEN OPENED BY THE CUSTOMER, REMOVED FROM ITS ORIGINAL PACKAGE AND PACKED IN A PLASTIC BAG. A VISUAL INSPECTION WAS PERFORMED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE PRODUCT, BUT THE SWIVEL WAS MISSING FROM THE PRODUCT PACKAGING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110509. CONCLUSION: IT IS HIGHLY UNLIKELY THAT THE BREATHING CIRCUIT KIT WOULD HAVE LEFT THE PRODUCTION LINE WITHOUT A SWIVEL FITTED. ALL BREATHING CIRCUIT KITS ARE 100% PRESSURE TESTED AND A MISSING SWIVEL IN THE BREATHING CIRCUIT KIT WOULD HAVE CAUSED IT TO FAIL THE PRESSURE TEST. IT IS MOST LIKELY THAT THE SWIVEL WAS LOST POST PRODUCTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT236 BREATHING CIRCUIT WAS MISSING THE Y-PIECE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT AN RT236 BREATHING CIRCUIT WAS MISSING THE Y-PIECE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 110509

    Patients

    Seq Age Sex Outcome Treatment
    1