BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2070085 · Received April 26, 2011

    Report

    Report Number
    9611451-2011-00269
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO RT225 INFANT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRES WAS TESTED USING A MULTIMETER. RESULTS: THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE OF THE FIRST INFANT BREATHING CIRCUIT WAS OUTSIDE THE REQUIRED SPECIFICATION. NO FAULT WAS FOUND WITH THE ELECTRICAL RESISTANCE OF THE SECOND BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100906. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE BREATHING CIRCUIT OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT KIT WAS "NOT HEATING." THIS WAS NOTICED BEFORE PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THE BREATHING CIRCUIT OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT KIT WAS "NOT HEATING". THIS WAS NOTICED BEFORE PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT225 100906

    Patients

    Seq Age Sex Outcome Treatment
    1