BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 1155893 · Received September 5, 2008

    Report

    Report Number
    9611451-2008-00512
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Report Date
    August 6, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS ASSOCIATED WITH THIS COMPLAINT ARE 050513, 050322 AND 071105 WHICH CORRESPOND WITH DEVICE MFR DATES OF 05/13/2005, 03/22/2005 AND 11/05/2007 RESPECTIVELY. METHOD: THE MR290HFV CHAMBERS WERE VISUALLY EXAMINED FOR CRACKS. RESULTS: ALL THE DEVICES HAVE A VERTICAL CRACK FROM THE CLEFT OF THE FRONT BAFFLE TO THE BASE OF THE DOME. THE CRACKS TO THE CHAMBERS HAVE OCCURRED WHILE IN USE ON THE SENSORMEDICS 3100B VENTILATOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE CHAMBER CRACKS HAVE MOST LIKELY RESULTED FROM OSCILLATORY STRESSES INDUCED BY THE HIGH FREQUENCY VENTILATOR. DESIGN IMPROVEMENTS WERE MADE TO THE MR290 CHAMBER WHICH RESULTED IN THE MR290HFV VARIANT RECOMMENDED FOR USE IN HIGH FREQUENCY APPLICATIONS. THIS IMPROVEMENT REDUCED THE INCIDENCE OF CRACKING BUT DID NOT ELIMINATE THE PROBLEM ENTIRELY. A CAPA HAS RECENTLY BEEN INITIATED TO FURTHER INVESTIGATE THE PROBLEM OF CRACKED CHAMBERS WHEN USED IN CONJUNCTION WITH HIGH FREQUENCY OSCILLATORY APPLICATIONS, IN PARTICULAR USE OF THE MR290HFV CHAMBER WITH THE SENSORMEDICS 3100B VENTILATOR. OUR MONITORING AND TRENDING OF INCIDENTS INVOLVING CRACKED MR290HFV CHAMBERS DUE TO USE WITH HIGH FREQNUENCY OSCILLATORS HAS A RATE OF OCCURENCE OF 0.022% WORLDWIDE IN THE LAST YEAR TO JULY 2008.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY REPORTED TO OUR DISTRIBUTOR THAT 3 UNITS OF THE MR290HFV HIGH FREQUENCY AUTOFEED HUMIDIFICATION CHAMBER CRACKED WHEN USED IN CONJUNCTION WITH THE SENSORMEDICS 31009 VENTILATOR. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290HFV

    Patients

    Seq Age Sex Outcome Treatment
    1 SENSORMEDICS 3100B VENTILATOR