BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 2182653 · Received July 28, 2011

    Report

    Report Number
    9611451-2011-00456
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR210 ADULT HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVED THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR210 HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR CRACKS. RESULTS: THE CHAMBER DOME WAS CRACKED NEAR THE BASE, BELOW ONE OF THE PORTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101129. CONCLUSION: NO INFORMATION WAS RECEIVED IN RELATION TO THE HUMMING VENTILATOR SETTINGS THAT WERE BEING USED AT THE TIME OF THE REPORTED CHAMBER CRACKS. BASED ON THE NATURE OF THE CRACK AND ON OUR KNOWLEDGE OF THE MR210 CHAMBER, IT IS LIKELY THAT THE CHAMBER CRACKED DUE TO THE USE OF PRESSURE IN EXCESS OF 20 KPA, WHICH IS THE MAXIMUM OPERATING PRESSURE INDICATED IN THE PRODUCT USER INSTRUCTIONS. ALL MR210 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR210 ADULT HUMIDIFICATION CHAMBER HAD CRACKED DURING USE. IT WAS FURTHER REPORTED THAT A HUMMING VENTILATOR WAS USED WITH THE CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR210 ADULT HUMIDIFICATION CHAMBER HAD CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR210 101129

    Patients

    Seq Age Sex Outcome Treatment
    1