BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1851082 · Received September 28, 2010

    Report

    Report Number
    9611451-2010-00585
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: TWO HOLES AND SEVERAL PARALLEL LINE INDENTATIONS WERE FOUND IN THE WATER FEEDSET TUBING OF THE RETURNED CHAMBER. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100209. CONCLUSION: THE RT236 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DUE TO THE HOLES IN THE WATER FEEDSET TUBING OF THE MR290V CHAMBER. WE ARE UNABLE TO CONFIRM THE SOURCE OF THE DAMAGE TO THE TUBING, HOWEVER IT APPEARS THAT THE TUBING MAY HAVE BEEN CLAMPED, POSSIBLY TO PREVENT WATER FLOW OR TO POSITION THE TUBING IN A CERTAIN MANNER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE'S FIELD REPRESENTATIVE THAT AN RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT DID NOT PASS THE SERVO-I VENTILATOR FUNCTIONAL TEST. THIS WAS NOTICED PRIOR TO PT USE. NO PT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST ON THE SERVO-I VENTILATOR PRIOR TO PATIENT USE. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE BREATHING CIRCUIT OPERATED PROPERLY WHEN THE MR290V AUTOFEED HUMIDIFICATION CHAMBER FROM THE RT236 BREATHING CIRCUIT KIT WAS REPLACED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100209

    Patients

    Seq Age Sex Outcome Treatment
    1