BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER

    MDR report key: 12594484 · Received October 7, 2021

    Report

    Report Number
    9611451-2021-01108
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 8, 2021
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE F&P 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER IS NOT CURRENTLY AVAILABLE FOR SALE IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K162553. METHOD: THE COMPLAINT HEATED BREATHING TUBE AS PART OF A 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR INVESTIGATION. OUR INVESTIGATION IS BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER REVEALED THAT THE TUBE WAS MELTED AND SOME PORTIONS OF THE TUBE WERE FLATTENED INDICATING A COMPRESSIVE LOAD MAY HAVE BEEN APPLIED ON TOP OF THE TUBE. THE CUSTOMER FURTHER REPORTED THAT THE HEATED BREATHING TUBE WAS PARTIALLY COVERED BY A BLANKET. CONCLUSION: DAMAGE TO THE HEATED BREATHING TUBE WAS CAUSED BY IT BEING PARTIALLY COVERED WITH A BLANKET. DURING PRODUCTION THE HEATER WIRES ARE 100% VISUALLY INSPECTED USING A CAMERA SYSTEM. THE HEATER WIRES ARE ALSO TESTED FOR RESISTANCE, CONTINUITY, POLARITY AND PITCH DURING PRODUCTION. BEFORE THE PRODUCT LEAVES THE LINE, A FULL FUNCTIONAL TEST IS CONDUCTED UNDER LOAD. THE AIRVO SYSTEM IS DESIGNED TO COMPLY WITH THE ELECTRICAL SAFETY STANDARD IEC 60601-1: 2005+A1:2012. THE CASE IS COMPOSED OF A FLAME RETARDANT MATERIAL. THE SURFACE TEMPERATURE OF THE HEATED BREATHING TUBE IS WITHIN THE LIMITS SPECIFIED BY ISO 8185 WITH REGARD TO HOT TUBE SURFACE TEMPERATURE NOT EXCEEDING 44° CELSIUS. THERE ARE MANY SAFETY FEATURES INCORPORATED INTO THE AIRVO TO PREVENT OVERHEATING AND FIRE. THESE INCLUDE: THE HEATER WIRES IN THE HEATED BREATHING TUBE ARE COATED WITH TEFLON, COMPLETELY INSULATING THEM FROM THE GAS PATH. THE PCB AT THE [PATIENT] END OF HOSE IS OVER MOULDED WITH THE THERMOPLASTIC POLYMER POLYPROPYLENE, ENSURING IT IS EXCLUDED FROM THE GAS PATH. THE AIRVO CONTAINS A TRANSIENT CURRENT DETECTOR, TCD. THIS TCD IS TESTED ON THE PRODUCTION LINE. IT IS ALSO CHECKED BY THE CONTROL SYSTEM WHEN THE AIRVO IS POWERING UP BEFORE EACH USE. AN 'OVER-TEMPERATURE' SENSOR WILL AUTOMATICALLY CUT POWER TO THE MOTOR, HEATER PLATE AND HEATER WIRE IF IT DETECTS ANY OVERHEATING. THE AIRVO IS CONSTANTLY CHECKING POWER IN THE HEATED BREATHING TUBE AND TURNS THE HEATER WIRE OFF IF THE MEASURED POWER IS TOO HIGH. THE USER INSTRUCTIONS THAT ACCOMPANY THE AIRVO 2 HUMIDIFIER INCLUDE THE FOLLOWING WARNING: ADDING HEAT, ABOVE AMBIENT LEVELS, TO ANY PART OF THE BREATHING TUBE OR INTERFACE, E.G. COVERING WITH A BLANKET, OR HEATING IT IN AN INCUBATOR OR OVERHEAD HEATER FOR A NEONATE, COULD RESULT IN SERIOUS INJURY. THE USER MANUAL INSTRUCTS THE USER TO "USE CONTINUOUS OXYGEN MONITORING ON PATIENTS WHO WOULD DESATURATE SIGNIFICANTLY IN THE EVENT OF DISRUPTION TO THEIR OXYGEN SUPPLY." THE USER MANUAL ALSO STATES THAT THE "AIRVO 2 IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH-FLOW, WARMED AND HUMIDIFIED RESPIRATORY GASES" AND THAT "THE UNIT IS NOT INTENDED FOR LIFE SUPPORT."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE (B)(4) REPORTED VIA A FISHER & PAYKEL (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF A 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER USED WITH A PT101 AIRVO 2 HUMIDIFIER WAS FOUND MELTED. IT WAS FURTHER REPORTED THAT THE HEATED BREATHING TUBE WAS PARTIALLY COVERED BY A BLANKET. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488200 AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER HEATED BREATHING TUBE BTT 900PT562 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1