BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1982058 · Received February 8, 2011

    Report

    Report Number
    9611451-2011-00060
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT235 INFANT BIAS FLOW DUAL-HEATED EVAQUA 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: THE RETURNED RT235 INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE RETURNED INFANT BREATHING CIRCUIT FAILED THE PRESSURE TEST. THE PRESSURE TEST RESULT WAS OUTSIDE THE REQUIRED SPECIFICATION. UPON SUBMERSION IN A WATER BATH, THE INFANT BREATHING CIRCUIT WAS FOUND TO BE LEAKING FROM THE SWIVEL, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100923. CONCLUSION: THE LEAK WAS CAUSED BY AN INSUFFICIENT SEAL BETWEEN THE TWO PARTS OF THE SWIVEL Y-PIECE THAT ARE HELD TOGETHER BY A SNAP-FIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED POST PRODUCTION. OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING SWIVEL LEAKS IN INFANT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CUSTOMER CARE SPECIALIST THAT AN RT235 INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE SERVO-I VENTILATOR LEAK TEST. THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CUSTOMER CARE SPECIALIST THAT AN RT235 INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE SERVO-I VENTILATOR LEAK TEST. THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 100923

    Patients

    Seq Age Sex Outcome Treatment
    1