BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT DUAL HEATED

    MDR report key: 3041022 · Received December 14, 2006

    Report

    Report Number
    9611451-2006-00016
    Event Type
    Malfunction
    Date Received
    December 14, 2006
    Date of Event
    September 25, 2006
    Report Date
    September 26, 2006
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE WE HAVE NOT RECEIVED THE DEVICE IMPLICATED IN THE INCIDENT, OR THE RESULTS OF INDEPENDENT TESTING. METHOD: PHOTOGRAPHS OF DEVICE FROM INCIDENT RECEIVED AND EXAMINED. SIX BREATHING CIRCUIT SAMPLES WITH VARYING LOT CODES FROM THE HOSPITAL'S STOCK WERE RECEIVED AND EVALUATED. RESULTS - INTERIM: VISUAL EXAMINATION OF PHOTOGRAPHS INDICATE FAILURE IN THE EXPIRATORY LIMB APPROX 20 - 30 CM FROM THE Y-PIECE (PT END). THIS APPEARS SIMILAR TO INCIDENTS PREVIOUSLY REPORTED, IE, MFR REPORT NUMBERS: 9611451-2005-00001, 00004, 00007, THAT RESULTED IN RECALL (B)(4). TO DATE, THE CAUSE OF THIS INCIDENT HAS NOT BEEN DETERMINED. OF THE SIX RETURNED SAMPLES FROM THE HOSPITAL'S STOCK, ONE WAS FOUND TO BE OUT OF SPEC. THE HEATER WIRE IN THE INSPIRATORY LIMB HAD A HIGH MEASURED RESISTANCE VALUE - POTENTIALLY AN OPEN CIRCUIT. THE CAUSE OF THIS IS TO BE DETERMINED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN TO DATE.

    Description of Event or Problem · 1

    FISHER & PAYKEL HEALTHCARE (FPHC) RECEIVED A REPORT FROM (B)(6) REGARDING AN ALLEGED FIRE. IT WAS REPORTED THAT THE PT WAS ON A FPHC RT110 BREATHING CIRCUIT WHEN AN ATTENDING NURSE NOTICED THE CIRCUIT DETERIORATING. THE PT WAS REPORTEDLY REMOVED WITHOUT APPARENT HARM, THE BREATHING CIRCUIT AND PILLOW WERE IMPACTED. WE UNDERSTAND THAT THE HOSPITAL PLANS TO RECEIVE AN INDEPENDENT EVAL OF THE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT DUAL HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HUMIDIFIER| PB840 VENTILATOR| FISHER & HEALTHCARE MR850 RESPIRATORY