BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1882683 · Received October 18, 2010

    Report

    Report Number
    9611451-2010-00619
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT240 ADULT DUAL-HEATED BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: A BOX WITH AN RT340 PRODUCT LABEL BUT CONTAINING 10 RT240 BREATHING CIRCUIT KITS WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR VISUAL INSPECTION. RESULTS: INSPECTION CONFIRMED THE REPORTED FAULT. THE INCORRECT PRODUCT LABEL (RT340 INSTEAD OF RT240) WAS ATTACHED TO THE BOX. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100819. CONCLUSION: THE PACKAGING HAD BEEN PRE-LABELLED WITH AN RT340 PRODUCT LABEL, HOWEVER, THE MANUFACTURING LINE CHANGED OVER TO THE RT240 BREATHING CIRCUIT. THIS RESULTED IN THE RT240 BREATHING CIRCUIT KITS BEING PACKED IN A BOX LABELED WITH RT340. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS INCLUDES INSTRUCTIONS STATING THAT A LABEL SHOULD ONLY BE AFFIXED TO A BOX IF THE BOX IS GOING TO BE PACKED. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE'S (FPH) CUSTOMER CARE SPECIALIST IN OUR US OFFICE "THAT A CASE OF RT340 WAS MISLABELED AND INSIDE WAS RT240". THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD. T240 100917

    Patients

    Seq Age Sex Outcome Treatment
    1