BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3016284 · Received March 21, 2013

    Report

    Report Number
    9611451-2013-00211
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 13, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS RECEIVED AND WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE EVAQUA EXPIRATORY LIMB REVEALED A HOLE ABOUT 38CM FROM THE PROXIMAL CONNECTOR. THE EVAQUA LIMB APPEARED TO HAVE BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 120827. CONCLUSION: WE WERE UNABLE TO DETERMINE HOW THE LIMB CAME TO BE DAMAGED. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS; FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT WAS FAULTY. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117072 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120827

    Patients

    Seq Age Sex Outcome Treatment
    1