BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3707450 · Received March 27, 2014

    Report

    Report Number
    9611451-2014-00268
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    February 22, 2014
    Report Date
    February 28, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 CHAMBER WAS RECEIVED FOR EVALUATION. IN ADDITION, OTHER DEVICES INVOLVED IN THE SET-UP WERE RECEIVED: MR850 HUMIDIFIER, SERIAL NUMBER 120918156162, MANUFACTURED 18 SEP 2012; 900MR805 HEATER WIRE ADAPTOR, LOT 090716, MANUFACTURED 16 JULY 2009; 900MR869 TEMPERATURE PROBE, LOT 110907 MANUFACTURED 7 SEP 2011. THESE DEVICES WERE ALL VISUALLY INSPECTED AND PERFORMANCE TESTED TO CHECK FOR MALFUNCTIONS. VISUAL INSPECTION OF THE COMPLAINT DEVICES: BOTH THE CHAMBER PORTS ON THE RETURNED MR290 WERE DEFORMED. NO STRESS MARKS OR CRACKS WERE FOUND AROUND THE DEFORMED PORTS. UPON VISUAL EXAMINATION NO DEFECT OR DAMAGE WAS NOTED TO THE RETURNED HUMIDIFIER, HEATER WIRE ADAPTOR OR TEMPERATURE PROBE. PERFORMANCE TEST RESULTS: MR850 HUMIDIFIER: THE RETURNED MR850 WAS PERFORMANCE TESTED USING A KNOWN WORKING CIRCUIT AND CHAMBER AND LEFT TO RUN FOR 48 HOURS. NO ALARMS OR FAULTS WERE NOTED DURING THE TEST PERIOD. THE MR850 ALSO PASSED ALL PERFORMANCE AND CALIBRATION TESTS AS PER THE PRODUCT TECHNICAL MANUAL. BOTH THE HEATER WIRE ADAPTOR AND THE TEMPERATURE PROBE FUNCTIONED NORMALLY WHEN TESTED. CONCLUSION: FURTHER INFORMATION RECEIVED FROM THE HOSPITAL REVEALED THAT THE SUBJECT MR290 CHAMBER HAD RUN DRY PRIOR TO THE OBSERVED DEFORMATION. THEY FURTHER CONFIRMED THAT THE MR850 HAD SOUNDED AN ALARM TO ALERT THEM OF THIS ISSUE. THE DEFORMATION OF THE CHAMBER LIKEY OCCURRED DUE TO EXCESSIVE HEAT IN THE CHAMBER CAUSED BY LOSS OF HUMIDITY ONCE THE CHAMBER RAN DRY. DEFORMATION WOULD ONLY OCCUR IF THE CHAMBER HAD BEEN ALLOWED CONTINUE OPERATION FOR A PROLONGED PERIOD OF TIME WITH NO HUMIDITY. WHEN THE CHAMBER RUNS OUT OF WATER THE MR850 DISPLAYS A VISUAL AND AUDIBLE ALARM TO ALERT THE CAREGIVER SO THAT THE WATER BAG CAN BE REPLACED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER STATE: ENSURE THERE IS A WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT WITHIN THE CHAMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE IS STILL TRYING TO OBTAIN FURTHER INFORMATION AND THE COMPLAINT DEVICES FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR850 HUMIDIFIER DISPLAYED 46 DEGREES CELSIUS AND THAT TWO MR290 HUMIDIFICATION CHAMBERS HAD DEFORMED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR850 HUMIDIFIER DISPLAYED 46 DEGREES CELSIUS AND THAT TWO MR290 HUMIDIFICATION CHAMBERS HAD DEFORMED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179065 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1305300392

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL 900MR869 TEMPERATURE PROBE| FISHER & PAYKEL MR850 HUMIDIFIER| FISHER & PAYKEL RT280 BREATHING CIRCUIT KIT| FISHER & PAYKEL MR850 HUMIDIFIER| FISHER & PAYKEL RT280 BREATHING CIRCUIT KIT| FISHER & PAYKEL 900MR805 HEATER WIRE ADAPTOR