BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2728561 · Received September 5, 2012

    Report

    Report Number
    9611451-2012-00604
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 7, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. OUR INVESTIGATION OF THIS COMPLAINT IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. THE COMPLAINT RT265 DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION WAS THEREFORE BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. THE PVC TUBES FROM THE VENTILATOR ADAPTOR KIT, SUPPLIED WITH THE RT265, WAS REPORTED TO BE DEFORMING AND DISCONNECTING AT THE VENTILATOR END. THE RELIABILITY OF THE CONNECTION BETWEEN THE VENTILATOR ADAPTOR AND PORT IS DEPENDENT ON HOW FAR THE PVC TUBE IS INSERTED INTO THE VENTILATOR PORT. THE PHOTOGRAPH SUPPLIED BY THE CUSTOMER IDENTIFIED THAT THE PVC TUBE IN THE EXPIRATORY LIMB WAS INSERTED APPROXIMATELY A QUARTER OF THE LENGTH OF THE PVC TUBE. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT THE INSPIRATORY AND EXPIRATORY CONNECTIONS OF THE LEONIE PLUS VENTILATOR WERE HOT AND AN RT265 INFANT BREATHING CIRCUIT BECAME DISCONNECTED FROM THE VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT THE INSPIRATORY AND EXPIRATORY CONNECTIONS OF THE LEONIE PLUS VENTILATOR WERE HOT AND AN RT265 INFANT BREATHING CIRCUIT BECAME DISCONNECTED FROM THE VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 120618

    Patients

    Seq Age Sex Outcome Treatment
    1