BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT EVAQUA BREATHING CIRCUIT

    MDR report key: 1220363 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00642
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR. THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K983112. THE RT340 BREATHING CIRCUIT WAS PRESSURE TESTED AND ALSO SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. TEST RESULTS INDICATE THAT THE PRESSURE DROP EXHIBITED BY THE BREATHING CIRCUIT IS OUTSIDE SPECIFICATION. UPON SUBMERSION IN THE WATER BATH, A LEAK WAS DETECTED AT THE EXPIRATORY TUBE CLOSE TO THE Y-PIECE. THIS HOLE WAS NOT EASILY VISIBLE TO THE NAKED EYE. CONCLUSION: ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS LIKELY THAT THE EXPIRATORY TUBE IN THIS CASE CAME INTO CONTACT WITH A SHARP OBJECT, FOR INSTANCE, THE WATER FEED SPIKE IN WHICH IS PART OF THE HUMIDIFICATION CHAMBER PACKED IN THE BREATHING CIRCUIT KIT. THE WATER FEED SPIKE IS ENCASED IN A PROTECTIVE COVERING, HOWEVER, IT IS POSSIBLE THAT THE SPIKE BECAME DISLODGED DURING MOVEMENT. AS THIS BREATHING CIRCUIT WOULD HAVE PASSED THE LEAK TEST FOLLOWING PRODUCTION, IT MOST LIKELY SUSTAINED DAMAGE DURING TRANSPORTATION OR DURING EQUIPMENT SET-UP. OUR MONITORING AND TRENDING OF LEAKS IN ADULT EVAQUA BREATHING CIRCUITS HAS A RATE OF OCCURRENCE WORLDWIDE IN THE LAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT AN RT340 ADULT EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST UPON SET-UP REPEATEDLY. REPLACEMENT OF THE BREATHING CIRCUIT SOLVED THE PROBLEM. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT340

    Patients

    Seq Age Sex Outcome Treatment
    1