BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2025465 · Received March 21, 2011

    Report

    Report Number
    9611451-2011-00179
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 23, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 100802, 090623, 100617. DEVICE MANUFACTURE DATES: 08/02/2010, 06/23/2010, 06/17/2010. THE COMPLAINT RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUITS HAVE ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND ARE CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). QUANTITY RETURNED TO FPH (B)(4): 1, LOT NUMBER: 100802, DEVICE MANUFACTURE DATE: 08/02/2010; 1, 090623, 06/23/2010; 1, 100617, 06/17/2010; 1, NOT PROVIDED, LOT NUMBER NOT PROVIDED. METHOD: A QUANTITY OF FOUR RT236 INFANT BREATHING CIRCUITS WERE RETURNED TO FPH (B)(4) FOR INSPECTION. THE RETURNED BREATHING CIRCUITS WERE PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: NO FAULT WAS FOUND WITH THE RETURNED INFANT BREATHING CIRCUIT WITH LOT LOT NUMBER 100802. THE PRESSURE TEST RESULT WAS WITHIN THE REQUIRED SPECIFICATION. THE OTHER THREE INFANT BREATHING CIRCUITS FAILED THE PRESSURE TEST. THE PRESSURE TEST RESULTS WERE OUTSIDE THE REQUIRED SPECIFICATION. UPON SUBMERSION IN A WATER BATH, LEAKS WERE DETECTED AROUND THE SWIVELS. A STRONG FORMATION OF BUBBLES WERE NOTICED AROUND THE SWIVELS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090623. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100617. 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 (B)(6) IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THREE RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUITS FAILED THE SERVO I VENTILATOR LEAK TEST. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THREE RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUITS FAILED THE SERVO I VENTILATOR LEAK TEST. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 REFER TO H10

    Patients

    Seq Age Sex Outcome Treatment
    1