BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 2104484 · Received May 26, 2011

    Report

    Report Number
    9611451-2011-00317
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT CHAMBER WAS RECEIVED AND VISUALLY INSPECTED. RESULTS: THE CHAMBER EXHIBITED ONE CRACK IN THE DOME, NEAR THE BRACKET, AND A LONG CRACK ALONG THE BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 061016. CONCLUSION: THE CRACKING OBSERVED ON THE RETURNED COMPLAINT CHAMBER IS CONSISTENT WITH THAT OF CHAMBERS USED ON A HIGH FREQUENCY VENTILATOR. THE MR290V CHAMBER IS LIKELY TO CRACK WHEN IT IS USED IN CONJUNCTION WITH A HIGH FREQUENCY OSCILLATING VENTILATOR. FISHER & PAYKEL HEALTHCARE MANUFACTURES THE MR290HFV CHAMBER, WHICH IS SPECIFICALLY DESIGNED FOR HIGH FREQUENCY VENTILATOR APPLICATIONS. SHOULD THE CRACK BE SIGNIFICANT ENOUGH TO CAUSE A DROP IN PRESSURE, THE VENTILATOR SHOULD ALARM, ALERTING THE USER TO REPLACE THE CHAMBER. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER THE FOLLOWING WARNINGS: SET APPROPRIATE VENTILATOR ALARMS; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. THE MR290 AUTOFEED HUMIDIFICATION CHAMBER FEATURES A FLOAT SYSTEM WHICH ALLOWS THE CHAMBER TO AUTOMATICALLY REFILL AND MAINTAIN AN APPROPRIATE WATER LEVEL. ALL MR290 CHAMBERS ARE PRESSURE TESTED AT THE END OF THE PRODUCTION PROCESS, JUST PRIOR TO PACKING, TO ENSURE THAT THEY ARE UNDAMAGED AND THAT THEY ARE ABLE TO OPERATE AS INTENDED. ANY CHAMBER WHICH DOES NOT PASS THE PRESSURE TEST IS REJECTED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THEY FOUND DEFECTS IN MR290 AUTOFEED HUMIDIFICATION CHAMBERS WHILE IN USE ON A SENSORMEDICS HFOV 3100A VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 061016

    Patients

    Seq Age Sex Outcome Treatment
    1 SENSORMEDICS HFOV 3100A VENTILATOR