BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1517196 · Received October 23, 2009

    Report

    Report Number
    9611451-2009-00556
    Event Type
    Other
    Date Received
    October 23, 2009
    Date of Event
    September 30, 2009
    Report Date
    September 30, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE INCIDENT WAS REPORTED BY A HOSPITAL IN (B) (6). THE SUBJECT MEDICAL DEVICE IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A DEVICE THAT IS. THE 510 (K) FOR THAT DEVICE IS K020332. THE COMPLAINT RT227 BREATHING CIRCUIT DOES NOT APPEAR TO BE AVAILABLE FOR RETURN TO FISHER & PAYKEL HEALTHCARE ('FPH') FOR EXAMINATION. WE BELIEVE THAT BEING A SINGLE-USE MEDICAL DEVICE, THE BREATHING CIRCUIT HAS MOST LIKELY BEEN DISCARDED FOLLOWING USE. FPH IS REQUESTING SPECIFIC INFORMATION WITH REGARDS TO THE PT STATUS AND OUTCOME. IN ADDITION, AN FPH REP IN THE (B) (4) HAS MADE CONTACT WITH MEDICAL STAFF AT THE HOSPITAL BOTH TO OBTAIN FURTHER INFO FOR A ROOT CAUSE ANALYSIS AS WELL AS RENDER TECHNICAL ASSISTANCE WITH POSSIBLE EQUIPMENT SET-UP MATTERS AND CONDENSATE MANAGEMENT. IN ORDER TO DETERMINE AND FURTHER ASSIST THE HOSPITAL WITH RESOLVING THE ISSUE, FPH IS IN THE PROCESS OF INVESTIGATING THE MATTER. WE ARE NOT YET IN A POSITION TO PROVIDE OUR FINAL RESULTS AT THIS STAGE. WE WILL SUBMIT A FOLLOW-UP REPORT IMMEDIATELY FOLLOWING THE COMPLETION OF OUR ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED OF CONDENSATION BUILD-UP WITHIN THE INSPIRATORY AND EXPIRATORY TUBES OF FISHER & PAYKEL HEALTHCARE'S RT227 INFANT BREATHING CIRCUIT. TYPICALLY, THE HOSPITAL UTILISES THE RT227 BREATHING CIRCUIT IN CONJUNCTION WITH FISHER & PAYKEL HEALTHCARE'S MR850 RESPIRATORY HUMIDIFIER AND SLE2000 VENTILATOR. ACCORDING TO THE HOSPITAL, THE CONDENSATION BUILD-UP RESULTED IN INADVERTENT INHALATION BY THE PT WITH SUBSEQUENT BRADYCARDIA AND DESATURATION. ATTENDING MEDICAL STAFF RESPONDED BY MANUALLY VENTILATING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MR850 RESPIRATORY HUMIDIFIER| DRAGER CALEO INCUBATOR| SLE2000 VENTILATOR| FISHER & PAYKEL HEALTHCARE'S