BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2639269 · Received July 3, 2012

    Report

    Report Number
    9611451-2012-00437
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    April 22, 2012
    Report Date
    June 8, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BREATHING CIRCUIT WAS NOT MADE AVAILABLE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: FROM THE INFORMATION RECEIVED, IT APPEARS THAT THE TEMPERATURE PROBE PORT AT THE CHAMBER END OF THE COMPLAINT RT340 CIRCUIT WAS BROKEN, AND FOR THIS REASON THE PROBE BECAME DISCONNECTED, AND CREATED A LEAK IN THE BREATHING SYSTEM. THE LEAK WAS DETECTED BY THE VENTILATOR, AND THE VENTILATOR ALARMED TO NOTIFY NURSING STAFF, WHO THEN MANUALLY BAGGED THE PATIENT WHILE THE BREATHING CIRCUIT WAS REPLACED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 111207. CONCLUSION: THE CUSTOMER HAS INFORMED US THAT THEY WERE ABLE TO SET UP THE TEMPERATURE PROBE CORRECTLY, AND THAT THEY USED THE CIRCUIT FOR FIVE DAYS WITHOUT ANY PROBLEM. THIS INDICATES THAT THE DAMAGE TO THE PROBE PORT OCCURRED DURING USE. HOWEVER, WITHOUT THE DEVICE OR A PHOTOGRAPH OF THE DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE. PLEASE ALSO NOTE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE HAVE RECEIVED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT ON A SETUP INVOLVING AN EVITA XL VENTILATOR AND AN RT340 ADULT BREATHING CIRCUIT NEEDED TO BE MANUALLY VENTILATED WHEN THE CHAMBER PROBE WAS FOUND DISCONNECTED FROM THE BREATHING CIRCUIT. THIS OCCURRED AFTER FIVE DAYS OF USE. NORMAL THERAPY RESUMED, ONCE THE CIRCUIT WAS REPLACED, AND THE PATIENT STABILISED. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 111207

    Patients

    Seq Age Sex Outcome Treatment
    1 EVITA XL VENTILATOR