BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2198395 · Received August 9, 2011

    Report

    Report Number
    9611451-2011-00479
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER, BUT WERE VISUALLY INSPECTED AND PERFORMANCE TESTED BY A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR (B)(4) REGIONAL OFFICE. THE COMPLAINT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED WITH THE FOLLOWING DEVICES INVOLVED IN THE SET UP - (B)(4) TEMPERATURE/FLOW PROBE (LOT 080731) AND (B)(4) HEATER WIRE ADAPTOR (LOT 010702) TO OUR REGIONAL OFFICE IN (B)(4). THE COMPLAINT CIRCUIT, AN (B)(4) INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS NOT RETURNED FOR EVALUATION. RESULTS: THE VISUAL INSPECTION REVEALED A CRACK ON THE FRONT CASE OF THE COMPLAINT MR850 RESPIRATORY HUMIDIFIER, WHICH IS LIKELY CAUSED BY PHYSICAL IMPACT DAMAGE. HOWEVER, THE TESTS CONDUCTED SHOWED THAT THIS HAD NO EFFECT ON THE OPERATING PERFORMANCE OF THE COMPLAINT HUMIDIFIER. THE COMPLAINT HUMIDIFIER PASSED THE CALIBRATION AND PERFORMANCE CHECKS OUTLINED IN THE MR850 PRODUCT TECHNICAL MANUAL. THE ALLEGED TEMPERATURE SPIKE WAS MOST LIKELY CAUSED BY THE PROBE BEING OUT. HE MR850 IS PROGRAMMED TO ALARM IF THE PROBE IS NOT INSERTED PROPERLY. ADDITIONAL TESTS WERE PERFORMED TO TEST THE 'HIGH TEMPERATURE' AND 'CHAMBER PROBE NOT INSERTED INTO THE BREATHING CIRCUIT PROPERLY' ALARMS. THE ALARMS FUNCTIONED AS INTENDED AND NO FAULT WAS FOUND WITH ANY OF THE ALARMS. NO FAULT WAS FOUND WITH THE (B)(4) TEMPERATURE/FLOW PROBE (LOT 080731) AND (B)(4) HEATER WIRE ADAPTOR (LOT 010702). CONCLUSION: NO FAULT WAS FOUND WITH THE OPERATION OR PERFORMANCE OF THE RETURNED MR850 HUMIDIFIER AND ITS ACCESSORIES. IT MUST BE NOTED THAT WITHOUT THE RETURN OF THE RT329 BREATHING CIRCUIT FOR EVALUATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE ALLEGED TEMPERATURE SPIKE. IT IS LIKELY THAT THE REPORTED INJURY WAS CAUSED BY AN ERROR DURING THE PROCESS OF EMPTYING THE CHAMBER BY THE HOSPITAL STAFF MEMBER, CAUSING THE WATER INSIDE THE CHAMBER TO ENTER THE BREATHING CIRCUIT AND REACH THE PATIENT. THE MR850 HAS NUMEROUS SAFETY FEATURES WHICH PREVENT HIGH TEMPERATURES BEING DELIVERED TO THE PATIENT. IT HAS OPERATIONAL ALARMS, WHICH ARE GENERATED WHEN A PROBLEM OCCURS WITH THE HUMIDIFIER. IT FEATURES AN AUDIBLE AND VISUAL ALARM WHICH ALERTS THE USER IF THE MEASURED TEMPERATURE EXCEEDS 41°C AND IF THIS OCCURS, IT DISABLES THE HEATER. THE HUMIDIFIER ALSO FEATURES A THERMAL CUT-OUT ON THE HEATER PLATE WHICH LIMITS THE MAXIMUM TEMPERATURE OF THE GAS ENTERING THE SYSTEM. OUR MR850 USER INSTRUCTIONS STATE THE FOLLOWING WARNING: "ENSURE THAT BOTH TEMPERATURE PROBE SENSORS ARE CORRECTLY AND SECURELY FITTED." "WHEN MOUNTING A HUMIDIFIER ADJACENT TO A PATIENT, ENSURE THAT THE HUMIDIFIER IS ALWAYS POSITIONED LOWER THAN THE PATIENT." "CHECK ACCESSORIES FOR ANY PHYSICAL DAMAGE BEFORE USE AND REPLACE IF DAMAGED." THE MR850 USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "PUSH THE CHAMBER PROBE AND AIRWAY PROBE INTO THE BREATHING CIRCUIT. MAKE SURE THE CHAMBER PROBE IS CORRECTLY LOCATED IN ITS KEY-WAY AND THAT BOTH PROBES ARE PUSHED HOME. THE PROBE LEAD CAN BE RESTRAINED USING BREATHING CIRCUIT CLIPS." A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE VISITED THE HOSPITAL UPON RECEIPT OF THIS COMPLAINT AND FURTHER TRAINING HAS BEEN SCHEDULED WITH THE HOSPITAL FOR DAY AND NIGHT STAFF MEMBERS. THE HOSPITAL HAS SINCE REPORTED THAT THE BABY IS DOING WELL AND THAT HIS SKIN IS HEALING WITH NO ADDITIONAL SKIN CARE REQUIRED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TEMPERATURE PROBE USED IN A SET UP INVOLVING AN MR850 RESPIRATORY HUMIDIFIER WAS "NOT PROPERLY SET" DURING USE, CAUSING THE DISPLAYED TEMPERATURE TO BE INCORRECT. UPON REINSERTING THE TEMPERATURE PROBE PROPERLY, THE HOSPITAL FURTHER REPORTED THAT THE TEMPERATURE DISPLAYED ON THE HUMIDIFIER ALLEGEDLY REACHED 60 DEGREE CELSIUS. THE HOSPITAL STAFF MEMBER THEN DECIDED TO EMPTY THE HUMIDIFICATION CHAMBER. IT WAS REPORTED THAT DURING THIS PROCESS OF EMPTYING THE CHAMBER, THE WATER "ROSE UP THE CIRCUIT" AND THE PATIENT ALLEGEDLY SUSTAINED SECOND DEGREE BURNS TO "THE NOSE, CHEEKS, BASE OF THE RIGHT EAR, MOUTH AND TONGUE, INSIDE THE NOSE AND ON THE RIGHT HAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 010831

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other (B)(4) INFANT CONTINUOUS FLOW BREATHING CIRCUIT| (B)(4) TEMPERATURE/FLOW PROBE (LOT 080731)| (B)(4) HEATER WIRE ADAPTOR (LOT 010702)