BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 3732461 · Received April 7, 2014

    Report

    Report Number
    9611451-2014-00279
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE COMPLAINT RT219 CIRCUIT KIT WAS RETURNED TO FISHER AND PAYKEL HEALTHCARE IN (B)(4)METHOD: THE COMPLAINT DEVICE WAS VISUALLY INSPECTED, A HEATER WIRE RESISTANCE TEST AND CONTINUITY TESTING OF THE INSPIRATORY HEATER WIRE WERE ALSO PERFORMED USING A CALIBRATED MULTIMETER. RESULTS: VISUAL INSPECTION REVEALED NO TO THE COMPLAINT DEVICE. ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE RESISTANCE WAS OPEN CIRCUIT. CONTINUITY TESTING SHOWED THAT THE OPEN CIRCUIT WAS LOCATED AT THE CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN, INSIDE THE OVER-MOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 131107 . CONCLUSION: THE CAUSE OF THE FAULT IS INSUFFICIENT CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN. AS A RESULT, ELECTRICAL CONTINUITY WAS NOT ACHIEVED FOR THE FULL PERIOD OF USE OF THE PRODUCT. RESISTANCE TESTS AND VISUAL INSPECTION ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE RESISTANCE BECAME OPEN CIRCUIT POST PRODUCTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT219 ADULT BREATHING CIRCUIT HAD AN INTERNAL WIRE BREAKAGE. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208561 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT219 131107

    Patients

    Seq Age Sex Outcome Treatment
    1