BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3273130 · Received August 8, 2013

    Report

    Report Number
    9611451-2013-00579
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Report Date
    July 9, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: QUANTITY AFFECTED: MANUFACTURING DATE: UNKNOWN 1, UNKNOWN; 120319, 1, 03/19/2012; 120824, 1, 08/24/2012; 130327, 1, 03/27/2013. THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE NOT EXPECTED TO THE RETURNED TO FPH FOR FURTHER INVESTIGATION. THE MEDICAL CENTER REPORTED TO THE FPH FIELD REPRESENTATIVE THAT THE SUBJECT CHAMBERS WERE DISCARDED AT THEIR FACILITY. AN ATTEMPT WAS ALSO MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED FAULT; HOWEVER, THE MEDICAL CENTER STATED THAT THEY "DIDN´T SAVED ANY INFORMATION". WITHOUT THE COMPLAINT DEVICES OR ADDITIONAL INFORMATION FROM THE MEDICAL CENTER WE ARE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, THE MEDICAL CENTER REPORTED THAT THE AFFECTED CHAMBER WITH LOT NUMBER 120824 WAS USED WITH INFANT FLOW SIPAP. IT IS KNOWN THAT SIPAP VENTILATOR IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF 80CMH2O. THE INTEGRITY OF THE CHAMBERS CAN BE AFFECTED WHEN PRESSURES EXCEED 80CMH2O. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE SUBJECT MR290 CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF RELEASE FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT". DISCARDED AT THE MEDICAL CENTER FACILITY.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN THE (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING AFTER TWO HOURS OF USE. IT WAS FURTHER REPORTED THAT THE DAMAGED CHAMBER WITH LOT NUMBER 120824 WAS USED WITH INFANT FLOW SIPAP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373678 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1