BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 3794992 · Received May 7, 2014

    Report

    Report Number
    9611451-2014-00407
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE INSPIRATORY HEATER WIRE WAS RESISTANCE TESTED USING A MULTIMETER. CONTINUITY TEST WAS ALSO PERFORMED TO DETERMINE THE ELECTRICAL CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PINS. RESULTS: THE RESISTANCE TEST SHOWED THE INSPIRATORY HEATER WIRE WAS WITHIN SPECIFICATION; HOWEVER THERE WAS NO ELECTRICAL CONNECTION BETWEEN THE HEATER WIRE AND THE LEFT HEATER WIRE PIN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130628. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT125 BREATHING CIRCUITS ARE RESISTANCE TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT AFTER RELEASE FOR DISTRIBUTION, POSSIBLY AS A RESULT OF AN INTERMITTENT CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE DISCONNECT ALARM SOUNDED ON AN MR850 HUMIDIFIER AFTER AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT HAD BEEN IN USE FOR FIVE HOURS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276487 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT125 130628

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER