BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2083921 · Received May 11, 2011

    Report

    Report Number
    9611451-2011-00290
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE THREE RETURNED COMPLAINT DEVICES WERE VISUALLY INSPECTED. THE CUSTOMER HAS REPORTED THAT THEY WERE USING THE NEW DRAEGER BABYLOG VN500 VENTILATOR. FISHER & PAYKEL HEALTHCARE HAS CONTACTED DRAEGER IN ORDER TO OBTAIN A BABYLOG VN500 FOR FURTHER TESTING, BUT THUS FAR WE HAVE NOT BEEN ABLE TO OBTAIN THIS VENTILATOR. RESULTS: THE VISUAL INSPECTION REVEALED THAT ALL THREE CHAMBERS WERE CRACKED IN ONE OR MORE PLACES, ALONG THE BASE AND ABOVE THE BAFLLE. ONE THE CHAMBER BASES ALSO BORE A SMALL STRESS MARK. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCT FOR EITHER OF THE LOT NUMBERS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. HOWEVER IT IS UNLIKELY THAT THE CRACKS TO THE CHAMBER WERE PRESENT AT THE TIME OF PRODUCTION. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THIS SUGGESTS THAT THE CRACKS OCCURRED POST PRODUCTION. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FINAL REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS HAD CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS HAD CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110113

    Patients

    Seq Age Sex Outcome Treatment
    1 BABYLOG VN500 VENTILATOR| (B)(4) INFANT BREATHING CIRCUIT| BABYLOG VN500 VENTILATOR