BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER.

    MDR report key: 2168216 · Received July 19, 2011

    Report

    Report Number
    9611451-2011-00424
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Report Date
    June 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: (B)(6) 2011. DEVICE MANUFACTURER DATE: 1 DEVICE: LOT 110404 - 04/04/2011, 1 DEVICE: LOT UNKNOWN - UNKNOWN. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENTS: (B)(6.) 2011 DEVICE MANUFACTURER DATE: 1 DEVICE: LOT 110404 - 04/04/2011; 1 DEVICE: LOT UNKNOWN - UNKNOWN. METHOD: ONE COMPLAINT CHAMBER, LOT 110404, WAS RETURNED AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION OF THE WATER FEEDSET TUBE REVEALED A BREAK AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE WATERBAG SPIKE. THE SURFACE OF THE BREAK WAS ROUGH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110404. CONCLUSION: THE FEEDSET TUBE ON THE COMPLAINT CHAMBER WAS FOUND BROKEN. THE BREAK WAS ROUGH SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE FEEDSET BEING CAUGHT OR UNDER TENSION. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. IT IS AN AUTOMATED PROCESS AND THE COMPLAINT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE WATER FEEDSET WAS DAMAGED POST-PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED AT THE CONNECTION BETWEEN THE FEED TUBE AND THE BAG SPIKE OF TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS DURING USE. THE HOSPITAL REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED AT THE CONNECTION BETWEEN THE FEED TUBE AND THE BAG SPIKE OF TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS DURING USE. THE HOSPITAL REPORTED THAT THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER. BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110404, UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT| RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT