BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2451614 · Received February 14, 2012

    Report

    Report Number
    9611451-2012-00076
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) FOR VISUAL INSPECTION. RESULTS: THE CHAMBER DOME WAS CRACKED NEAR THE HINGE BRACKET. THE ALUMINIUM BASE WAS BENT UPWARD, NEAR THE RIGHT HINGE BRACKET. THE SECONDARY FLOAT INSIDE THE CHAMBER DOME WAS STUCK AND COULD ONLY BE MOVED WHEN THE CHAMBER WAS TAPPED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 041203. CONCLUSION: IT IS MOST LIKELY THAT THE PHYSICAL DAMAGES TO THE RETURNED MR290V CHAMBER WERE DUE TO IMPACT. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THIS SUGGESTS THAT THE SUBJECT CHAMBER WAS DAMAGED POST PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER 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." FPH HAS NOT RECEIVED COMPLAINTS RELATED TO SECONDARY FLOAT FAILURES IN MR290 CHAMBERS IN THE LAST YEAR TO THE END OF (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE FLOATS INSIDE AN MR290V VENTED HUMIDIFICATION CHAMBER WERE "NEVER RELEASED PROPERLY", CAUSING THE WATER TO OVERFLOW. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE FLOATS INSIDE AN MR290V VENTED HUMIDIFICATION CHAMBER WERE "NEVER RELEASED PROPERLY", CAUSING THE WATER TO OVERFLOW. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 041203

    Patients

    Seq Age Sex Outcome Treatment
    1