BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 1057907 · Received June 4, 2008

    Report

    Report Number
    9611451-2008-00339
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Report Date
    April 25, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED THIS COMPLAINT STATING MULTIPLE EVENT DATES IN 2008. THE REPORT STATED THAT ALL THREE MR290HFV HUMIDIFICATION CHAMBERS WERE USED ON THE SAME PT. THE REPORT DID NOT SPECIFY IF THE FOURTH MR290HFV HUMIDIFICATION CHAMBER WAS USED ON THE SAME PT OR ON A DIFFERENT PT. D4: THE FOLLOWING LOT NUMBERS WERE PROVIDED FOR EVENTS THAT OCCURRED IN 2008: 070301 AND 070322. THE DEVICE WAS NOT RETURNED TO THE MFR. INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE CRACKS ARE LIKELY TO HAVE OCCURRED DURING USE FROM STRESSES INDUCED BY HIGH FREQUENCY OSCILLATIONS ON THE PLASTIC CHAMBER DOME FROM THE HIGH FREQUENCY OSCILLATORY VENTILATOR. CONCLUSION: CRACKS IN THE PLASTIC CHAMBER DOME CAN OCCUR WHEN HIGH FREQUENCY OSCILLATIONS ARE ENCOUNTERED. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0255%. WE HAVE AN OPEN CAPA PROJECT TO ADDRESS THIS ISSUE AND TO IMPLEMENT POTENTIAL DESIGN SOLUTIONS TO PREVENT RECURRENCE IN THE FUTURE.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT FOUR MR290HFV HUMIDIFICATION CHAMBERS CRACKED AND LEAKED DURING PT USE. IT WAS REPORTED THAT THE PT WAS ON HIGH FREQUENCY OSCILLATORY VENTILATION. 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