BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1940002 · Received December 28, 2010

    Report

    Report Number
    9611451-2010-00795
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT204 BREATHING CIRCUIT 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. METHOD: THE LATCH STRENGTH OF THE ELBOW CONNECTOR ON THE RETURNED INSPIRATORY LIMB OF THE COMPLAINT BREATHING CIRCUIT WAS TESTED USING A FORCE GAUGE. RESULTS: THE LATCH STRENGTH ON THE CONNECTOR WAS FOUND TO BE LESS THAN ON A NORMAL BREATHING CIRCUIT, CONFIRMING THE REPORTED FAULT THAT THE CONNECTOR WAS DAMAGED. A LOT CHECK COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: OUR RESULTS SHOW THAT THE LATCH STRENGTH BETWEEN THE HEATER WIRE PLUG AND THE ELBOW CONNECTOR WAS OUTSIDE PRODUCT SPECIFICATIONS, WHICH LIKELY RESULTED IN THE PARTS BECOMING LOOSE AS REPORTED. WE WERE UNABLE TO DETERMINE THE CAUSE OF THE LOOSE CONNECTOR. A LEAK IN THE SYSTEM WILL USUALLY BE DETECTED BY AN ALARM ISSUING FROM THE VENTILATOR. THE RT204 USER INSTRUCTIONS STATE THE FOLLOWING WARNINGS: 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. FISHER & PAYKEL HEALTHCARE HAS RECEIVED ONE OTHER COMPLAINT OF THIS NATURE IN THE PAST YEAR TO THE END OF NOVEMBER 2010.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A CONNECTOR ON AN RT204 BREATHING CIRCUIT CRACKED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT204 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1