BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3000579 · Received March 12, 2013

    Report

    Report Number
    9611451-2013-00179
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 30, 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 33CM 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 OF THIS NATURE FOR LOT 120904. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AIR LEAKED FROM THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AIR LEAKED FROM THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102821 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120904

    Patients

    Seq Age Sex Outcome Treatment
    1