BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 2114993 · Received June 7, 2011

    Report

    Report Number
    9611451-2011-00329
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Report Date
    May 10, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NUMBER: 1, QUANTITY: 1, LOT NUMBER: 100220, MANUFACTURING DATE: 02/20/2010; 2, 1, 101014, 10/14/2010; 3, 1, 101014, 10/14/2010; 4, 1, 090614, 06/14/2009; 5, 1, 090624, 06/24/2009; 6, 8, 101014, 10/14/2010. METHOD: A TOTAL OF 13 COMPLAINT MR290HFV CHAMBERS WERE RETURNED TO FPH (B)(4) FOR INSPECTION. DEVICES # 1 TO 4 (WITH LOT NUMBERS 100220, 101014, 101014 AND 090614) WERE PRESSURE TESTED FOR LEAKS AND DEVICE # 5 (LOT NUMBER 090624) WAS VISUALLY INSPECTED FOR DAMAGE. DEVICES # 6 (LOT NUMBER 101014) WERE NOT INSPECTED AS THEY WERE RETURNED UNUSED AND STILL IN ITS ORIGINAL PACKAGING. RESULTS: NO FAULT WAS FOUND WITH DEVICES # 1 TO 4. THE PRESSURE TEST RESULTS WERE WITHIN THE REQUIRED SPECIFICATION. VISUAL INSPECTION OF DEVICE # 5 REVEALED THAT THE CHAMBER DOME WAS CRACKED AND THE BASE WAS DENTED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090624. CONCLUSION: EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. AS THE CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION, THIS SUGGESTS THAT THE AFFECTED CHAMBER WAS DAMAGED POST PRODUCTION, POSSIBLY DURING TRANSPORT OR STORAGE. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT (B)(4) HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBERS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A QUANTITY OF 13 (B)(4) HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBERS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A QUANTITY OF 13 MR290HFV HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBERS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290HFV NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1