BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE RESUSCITATION CIRCUIT KIT

    MDR report key: 1841434 · Received September 15, 2010

    Report

    Report Number
    9611451-2010-00549
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 17, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED (B)(4) SINGLE USE RESUSCITATION CIRCUIT KIT WAS VISUALLY INSPECTED. THE DEVICE HISTORY RECORD (DHR) SUMMARY FORMS OF BOTH 72 MM (RD807) AND 60 MM (RD806) MASKS WERE ALSO REVIEWED TO CHECK WHETHER BOTH SIZES OF MASKS WERE MFG ON THE GIVEN LOT DATE. RESULTS: THE REPORTED FAULT WAS CONFIRMED. THE RETURNED CIRCUIT KIT CONTAINED 10 RD807 72 MM MASKS INSTEAD OF RD806 60 MM MASKS. BASED ON THE DHR REVIEW, 72MM AND 60MM MASKS WERE NOT MFG ON THE SAME DAY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE DHR REVIEW REVEALED THAT THERE WAS NO LABEL MIX UP BETWEEN THE TWO SIZES OF MASKS. THE REPORTED FAULT IS MOST LIKELY DUE TO INCORRECT PACKING DURING THE ASSEMBLY PROCESS. FPH HAS NOT RECEIVED COMPLAINTS OF ANY SIMILAR INCIDENTS FOR THESE PARTICULAR PRODUCTS. REPLACEMENT MASKS HAVE BEEN SUPPLIED TO THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CUSTOMER CARE SPECIALIST AT OUR US OFFICE THAT (B)(4) SINGLE USE RESUSCITATION CIRCUIT KIT CONTAINED 72MM (P/N RD807) MASKS INSTEAD OF 60 MM (P/N RD806) MASKS. THIS WAS FOUND PRIOR TO PT USE, RIGHT OUT OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE RESUSCITATION CIRCUIT KIT BTL FISHER & PAYKEL HEALTHCARE, LTD. 900RD016 100507

    Patients

    Seq Age Sex Outcome Treatment
    1