BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 5063237 · Received September 8, 2015

    Report

    Report Number
    9611451-2015-00394
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    July 20, 2015
    Report Date
    September 4, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR730 HUMIDIFIER WAS RETURNED TO FPH IN (B)(4) FOR FURTHER EVALUATION WITH THE FOLLOWING DEVICES INVOLVED IN THE SET UP: THE FPH 900MR901 HEATER WIRE ADAPTOR (LOT 020513, MANUFACTURED ON MAY 13, 2002). THE FPH 900MR560 TEMPERATURE PROBE (LOT 100202, MANUFACTURED ON FEB 2, 2010). THE HUMIDIFIER WAS PERFORMANCE AND FUNCTIONAL TESTED AND THE HEATER WIRE ADAPTOR AND THE TEMPERATURE PROBE WERE FUNCTIONAL TESTED. RESULTS: THE MR730 HUMIDIFIER, THE 900MR901 HEATER WIRE ADAPTOR AND 900MR560 TEMPERATURE PROBE PASSED THE FUNCTIONAL TESTS. ADDITIONALLY, THE MR730 PASSED THE PERFORMANCE TESTS AS PER THE PRODUCT TECHNICAL MANUAL. THE MR730 HUMIDIFIER DID NOT ACTIVATE AN AUDIBLE AND VISUAL HEATER WIRE ADAPTOR ALARM WHEN THE 900MR901 HEATER WIRE ADAPTOR WAS CONNECTED TO THE HUMIDIFIER DURING A THREE DAY TEST (FIVE HOURS / DAY). ALSO A KNOWN WORKING INSPIRATORY LIMB WAS ABLE TO HEAT UP WITH THIS SYSTEM. BOTH THE MR730'S CHAMBER THERMISTOR AND THE AIRWAY THERMISTOR WERE WITHIN SPECIFICATION. THE 900MR560 TEMPERATURE PROBE WAS ALSO PERFORMANCE TESTED FOR THREE DAYS (FIVE HOURS / DAY) AND THE HEATER BASE DID NOT ALARM. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED MR730 HUMIDIFIER, THE 900MR901 HEATER WIRE ADAPTOR AND THE 900MR560 TEMPERATURE PROBE, AS THEY PASSED ALL FUNCTIONAL CHECKS CONDUCTED. ADDITIONALLY, THE RETURNED MR730 HUMIDIFIER PASSED ALL CONDUCTED PERFORMANCE TESTS AS PER THE PRODUCT TECHNICAL MANUAL. THE CUSTOMER ALSO REPORTED THAT THE "TEMPERATURE PROBE WAS NOT CONNECTED PROPERLY" AND THE HUMIDIFIER WAS ALARMING. THE AIRWAY TEMPERATURE AND FLOW PROBE MEASURE GAS TEMPERATURE AND FLOW RATE IN A BREATHING CIRCUIT. WHEN THE TEMPERATURE PROBE BECOMES DETACHED, THE HUMIDIFIER CANNOT ACCURATELY SENSE THE TEMPERATURE IN THE FLOW IN THE CIRCUIT AND COMPENSATES THE LOW TEMPERATURE MEASURED. THE HUMIDIFIER ACCURATELY ALARMED AS EXPECTED AND DISPLAYED A LOW TEMPERATURE ALARM TO THE CAREGIVER. THE FISHER & PAYKEL MR730 DUAL SERVO CONTROLLED HEATED RESPIRATORY HUMIDIFIERS ARE USED TO WARM AND ADD HUMIDITY TO GASES DELIVERED TO PATIENTS REQUIRING MECHANICAL VENTILATION OR POSITIVE PRESSURE BREATHING ASSISTANCE VIA AN ENDOTRACHEAL TUBE OR FACE MASK. THE WARMTH AND MOISTURE ARE SUPPLIED BY PASSING THE GAS OVER HEATED WATER AND THE TEMPERATURE OF THE GAS FLOWING THROUGH THE BREATHING CIRCUIT CAN BE MAINTAINED BY A HEATER WIRE. TEMPERATURE IS CONTROLLED ACCURATELY AND MEASURED VIA TEMPERATURE PROBES LOCATED AT THE PATIENT END OF THE DELIVERY TUBE AND AT THE HUMIDIFICATION CHAMBER OUTLET. THE MR730 HUMIDIFIER COMPLIES WITH IEC60601-1, THE INTERNATIONAL ELECTROTECHNICAL COMMISSION REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT. FOLLOWING THIS INCIDENT, THE HOSPITAL REQUESTED THAT FPH PROVIDE ADDITIONAL TRAINING FOR THEIR STAFF. AN FPH REPRESENTATIVE HAS SUBSEQUENTLY VISITED THE HOSPITAL AND CONDUCTED A TRAINING SESSION WITH THE HOSPITAL STAFF MEMBERS (NURSES AND MANAGERS). SWING TAGS HAVE ALSO BEEN OFFERED TO THE HOSPITAL AS AN AID TO INSTRUCTION AND TROUBLESHOOTING. SINCE THE VISIT OF OUR FPH REPRESENTATIVE, THE HOSPITAL HAS DECIDED TO PURCHASE MR850 HUMIDIFIERS TO REPLACE ALL MR730 IN THE UNIT, AS THE MR730 HUMIDIFIER WAS MADE OBSOLETE IN 2003. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR730 HUMIDIFIER STATE THE FOLLOWING: UNLESS THE CAUSE AND EFFECTS OF ANY ALARM ARE UNDERSTOOD AND ASSESSED TO BE OF NO HAZARD TO THE PATIENT, THE HUMIDIFIER SHOULD BE IMMEDIATELY SWITCHED OFF AND DISCONNECTED FROM THE PATIENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A BABY SET UP ON A BC161 CIRCUIT KIT AND MR730 HUMIDIFIER HAD ALLEGEDLY SUSTAINED A BURN ON THE NOSE. WE HAVE SUBSEQUENTLY BEEN INFORMED BY THE HOSPITAL THAT THE BABY IS "BEING TREATED BY THE WOUND CLINIC, AND AT HOME WITH THE FAMILY. EXPECTED TO MAKE A FULL RECOVERY WITH MINIMAL / NO SCARING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594051 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR730

    Patients

    Seq Age Sex Outcome Treatment
    1