BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 3091010 · Received May 2, 2013

    Report

    Report Number
    9611451-2013-00355
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT330 CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION AS IT IS NOT AVAILABLE FROM THE HOSPITAL. OUR EVALUATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND INFORMATION PROVIDED BY THE CUSTOMER. WE WERE NOT ABLE TO CONFIRM THE REPORTED FAULT OR DETERMINE THE CAUSE OF THE REPORTED EVENT. IF THE TEMPERATURE PROBE WAS NOT CONNECTED CORRECTLY AS PER THE USER INSTRUCTIONS, INCORRECT SET UP IS MOST LIKELY THE REASON FOR THE DISCONNECTION OF THE TEMPERATURE PROBE FROM THE RT330 CIRCUIT. THE TEMPERATURE PROBE WAS REPORTED TO HAVE BEEN FOUND DISCONNECTED DURING USE WITH AN RT330 BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT330 CIRCUIT CONTAIN A PICTORIAL DIAGRAM THAT INSTRUCTS THE USER TO CONNECT THE TEMPERATURE PROBE TO THE RT330 CIRCUIT CORRECTLY. THIS USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE".

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT330 CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE REPORTED THAT DURING A HOSPITAL VISIT, THE TEMPERATURE PROBE WAS FOUND TO BE DISCONNECTED FROM AN RT330 INFANT OPTIFLOW CIRCUIT DURING PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE REPORTED THAT DURING A HOSPITAL VISIT, THE TEMPERATURE PROBE WAS FOUND TO BE DISCONNECTED FROM AN RT330 INFANT OPTIFLOW CIRCUIT DURING PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192559 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT330

    Patients

    Seq Age Sex Outcome Treatment
    1