BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2182661 · Received July 28, 2011

    Report

    Report Number
    9611451-2011-00451
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE RETURNED RT319 ADULT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE. VISUAL INSPECTION REVEALED THAT THE INSPIRATORY HEATER WIRE PIN WAS BENT. THIS PREVENTED THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET DURING SETUP OF THE BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 101216. CONCLUSION: IT IS POSSIBLE FOR THE USER TO BEND THE HEATER WIRE PINS IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT HAD BENT HEATER PINS IN THE INSPIRATORY TUBE. THIS WAS OBSERVED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT319 101216

    Patients

    Seq Age Sex Outcome Treatment
    1