BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2962805 · Received February 14, 2013

    Report

    Report Number
    9611451-2013-00100
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 120823 (3 UNITS), 121018 (3 UNITS). DEVICE MANUFACTURER DATES: AUGUST 23, 2012 AND OCTOBER, 18 2012. METHOD: THE COMPLAINT RT236 BREATHING CIRCUIT KITS (KIT INCLUDES MR290 CHAMBERS) WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INSPECTION AS THEY HAVE BEEN DISCARDED BY THE HOSPITAL. OUR INVESTIGATION WAS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: IT WAS REPORTED THAT THE WATER CHAMBERS AND THE Y-PIECES OF THE RT236 BREATHING CIRCUIT KITS WERE CRACKED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBERS 120823 AND 121018. CONCLUSION: WITHOUT THE COMPLAINT DEVICES, WE WERE UNABLE TO CONFIRM THE REPORTED FAULT AND DETERMINE ANY PARTICULAR FAILURE MODE. EVERY MR290 CHAMBER IS PRESSURE TESTED TO (B)(4) FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE CUSTOMER HAS REPORTED THAT THE CRACKS APPEARED AFTER 3 - 4 DAYS OF USE, INDICATING THE FAULT OCCURRED POST PRODUCTION. ALL BREATHING CIRCUITS ARE PRESSURE AND FLOW TESTED BEFORE LEAVING THE PRODUCTION LINE. THIS AN AUTOMATED PROCESS AND THE CIRCUIT AND Y-PIECE WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT236 INFANT BREATHING CIRCUIT STATE: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". "SET APPROPRIATE VENTILATOR ALARMS".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO AN FPH FIELD REPRESENTATIVE THAT THE WATER CHAMBERS AND THE Y-PIECE OF SIX RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT KITS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65988 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1