BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT OXYGEN THERAPY BREATHING CIRCUIT

    MDR report key: 3943086 · Received July 18, 2014

    Report

    Report Number
    9611451-2014-00618
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 24, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RT203 ADULT OXYGEN THERAPY BREATHING CIRCUIT 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. THE COMPLAINT RT203 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. OUR INVESTIGATION IS THEREFORE BASED ON INFORMATION PROVIDED BY THE HOSPITAL. FOLLOWING RECEIPT OF THIS COMPLAINT AN FPH FIELD REPRESENTATIVE VISITED THE HOSPITAL TO GAIN MORE INFORMATION. THE REPRESENTATIVE MET WITH HOSPITAL STAFF AND THE SUPPLIER OF THE MASK. THE HOSPITAL INFORMED THE REPRESENTATIVE THAT THERE WAS NO ISSUE WITH THE RT203. THE RT203 IS MANUFACTURED WITH A 22MM FEMALE CONNECTOR WHICH CONFORMS TO THE STANDARD ISO 5356-1 FOR CONICAL CONNECTORS. FROM THE PHOTOGRAPHS PROVIDED BY THE HOSPITAL, IT APPEARS THE UNOMEDICAL MASK MODEL INVOLVED IN THIS REPORT DOES NOT HAVE THE SAME ISO 5356-1 CONICAL CONNECTOR. THEREFORE THE USE OF THESE TWO PRODUCTS TOGETHER WAS INCOMPATIBLE. THE HOSPITAL IS WORKING WITH THE MASK SUPPLIER TO ADDRESS THIS ISSUE AND CONSIDERING SWITCHING TO A FISHER & PAYKEL HEALTHCARE PRODUCT INSTEAD. AN FPH REPRESENTATIVE IS PROVIDING FURTHER TRAINING AND SUPPORT REGARDING THE CORRECT USE AND COMPATIBILITY OF THE RT203 AND ITS ISO 5356-1 CONICAL CONNECTORS. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT203 ADULT DUAL-HEATED BREATHING CIRCUIT STATE THE FOLLOWING: - "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA THE (B)(6), THAT AN RT203 ADULT OXYGEN THERAPY BREATHING CIRCUIT BECAME DISCONNECTED FROM A UNOMEDICAL AEROSOL ADULT MASK DURING USE. THE PATIENT WAS TERMINALLY ILL DUE TO RESPIRATORY PROBLEMS. IT WAS REPORTED THAT THE PATIENT DIED, POSSIBLY AS A RESULT OF LACK OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421523 ADULT OXYGEN THERAPY BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT203

    Patients

    Seq Age Sex Outcome Treatment
    1 Death UNOMEDICAL AEROSOL MASK