BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1883617 · Received October 26, 2010

    Report

    Report Number
    9611451-2010-00640
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER HAS ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) AND IS CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR THE REPORTED PUNCTURE. RESULTS: VISUAL INSPECTION CONFIRMED THE REPORTED FAULT. THE FILTER OF THE WATER BAG SPIKE HAD A 5MM CUT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100429. CONCLUSION: THE WATER BAG SPIKE FILTER OF AN MR290V HUMIDIFICATION CHAMBER IS MANUFACTURED BY A SUPPLIER TO FISHER & PAYKEL HEALTHCARE (FPH), AND ASSEMBLED INTO THE WATER BAG SPIKE ON THE FPH'S PRODUCTION LINE. IT IS LIKELY THAT THE FILTER WAS DAMAGED DURING THE SUPPLIER'S MANUFACTURING PROCESS. HOWEVER, THE DAMAGE WAS NOT NOTICED DURING THE SUPPLIER'S INSPECTION OR FPH ASSEMBLY PROCESSES, AS THE CAP OF THE WATER BAG SPIKE FILTER IS CLOSED WHILE BEING PRESSURE TESTED. THIS MATTER HAS BEEN BROUGHT TO THE ATTENTION OF OUR SUPPLIER FOR THEIR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL (FPH) FIELD REPRESENTATIVE THAT THE FILTER OF THE WATER BAG SPIKE OF AN MR290V VENTED AUTOFEED HUMIFICATION CHAMBER WAS PUNCTURED. IT WAS NOTICED BEFORE USE ON A PATIENT. NO CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL (FPH) FIELD REPRESENTATIVE THAT THE FILTER OF THE WATER BAG SPIKE OF AN MR290V VENTED AUTOFEED HUMIFICATION CHAMBER WAS PUNCTURED. IT WAS NOTICED BEFORE USE ON A PATIENT. NO CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100429

    Patients

    Seq Age Sex Outcome Treatment
    1