BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY BREATHING CIRCUIT

    MDR report key: 1071373 · Received July 8, 2008

    Report

    Report Number
    9611451-2008-00418
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 21, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE. THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED FOR BENT HEATERWIRE PINS. RESULTS - ONE OF THE HEATERWIRE CONNECTOR PINS IS SPLIT AND HAD BEEN BENT THROUGH FURTHER FORCE WHEN TRYING TO INSERT THE HEATERWIRE ADAPTER. THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION - THE HEATERWIRE PINS WERE POSSIBLY DAMAGED DURING PRODUCTION. AN IMPROVEMENT WAS MADE TO THE PRODUCTION PROCESS TO PREVENT BENT PINS PASSING THE PRODUCTION TEST. THE LOT NUMBER SHOWS THAT THIS EVENT OCCURRED BEFORE THE PRODUCTION IMPROVEMENT. OUR MONITORING AND TRENDING FOR ADULT BENT HEATER WIRE PINS HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0013%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THROUGH OUR DISTRIBUTOR THAT WHILE AN ADULT INSPIRATORY BREATHING CIRCUIT WAS BEING SET UP TO A VENTILATOR, IT WAS FOUND OUT THAT THE INSPIRATORY CIRCUIT HAD BENT HEATERWIRE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT105 070913

    Patients

    Seq Age Sex Outcome Treatment
    1