BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP HUMIDIFIER

    MDR report key: 2385467 · Received December 21, 2011

    Report

    Report Number
    9611451-2011-00797
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Report Date
    November 23, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K040941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HC604 CPAP DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. THE CONTROL PCB WAS TESTED SEPARATELY TO CHECK FOR ERROR CODES. RESULTS: THE ERROR LOG OF THE CONTROL PCB FROM THE COMPLAINT DEVICE CONTAINS THE E2 ERROR MESSAGE, CONFIRMING THE REPORTED FAULT. NO ERROR CODE WAS GENERATED WHEN THE CONTROL PCB WAS TESTED WITH A KNOWN FUNCTIONAL HEATED BREATHING TUBE. AN 6MM TRIANGULAR SHAPE HOLE WAS FOUND ON THE EXTERNAL CASING OF THE DEVICE AND THERE WAS A STRONG BURNT ODOR COMING FROM THE COMPLAINT DEVICE. UPON OPENING OF THE CASE, THERE WAS THERMAL DAMAGE OBSERVED ON THE SIDE OF THE LOWER ENCLOSURE AND ON THE POWER PCB. INTERNAL INSPECTION REVEALED THAT WATER "TIDE" MARK WAS OBSERVED ON THE POWER PCB SIDE OF THE INSIDE SURFACE OF THE ENCLOSURE AND THE OVERMOULD ON THE POWER PCB HAD STARTED TO LIFT. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 091209. CONCLUSION: THE E2 ERROR CODE RELATES TO A HEATED BREATHING TUBE FAULT AND IT IS LIKELY THAT THE CUSTOMER USED A DEFECTIVE HEATED BREATHING TUBE. WATER INGRESS IS MOST LIKELY THE CAUSE OF THE FAILURE AS WATER "TIDE" MARK ON THE INSIDE SURFACE OF THE ENCLOSURE INDICATES THAT THE UNIT HAD BEEN ON ITS SIDE AND WATER FROM THE CHAMBER HAD ENTERED THE UNIT THROUGH THE ENCLOSURE GAPS. WHEN THE UNIT IS CONNECTED TO POWER, THE CONTACT BETWEEN WATER AND THE MAINS TRACKS ON THE POWER PCB CAN CAUSE ARCING THAT LEADS TO THE THERMAL DAMAGE. OUR CAPA TO ADDRESS THIS ISSUE IS COMPLETE AND TWO ACTIONS HAVE BEEN TAKEN AS A RESULT. THE FIRST OF THESE WAS IMPLEMENTED IN JANUARY 2008 AND INVOLVED THE SHAPE OF THE AIRBOX INSIDE THE UNIT WHERE THE POWER PCB SITS. THIS WAS MODIFIED TO ENSURE THAT WATER CAN RUN AWAY FROM THE LOWER PORTION OF THE POWER PCB WHEN THE UNIT IS IN AN UPRIGHT POSITION. THE SECOND WAS TO OVERMOULD PLASTIC MATERIAL (MACROMELT OM-652) ONTO THE HIGH VOLTAGE (MAINS) PART OF THE POWER PCB. THIS PREVENTS WATER COMING INTO CONTACT WITH THE TRACKS ON THE AREA OF THE BOARD WHERE WATER CAUSES ARCING THAT LEADS TO THIS OVERHEATING EVENT. THIS CHANGE WAS INTRODUCED INTO PRODUCTION IN SEPTEMBER 2008. THE HC604 IS DESIGNED TO THE ELECTRICAL SAFETY STANDARD (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE HC604 CPAP UNIT HAD AN E2 ERROR CODE AND A BURNING SMELL. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP HUMIDIFIER BZD BZD FISHER & PAYKEL HEALTHCARE LTD HC604

    Patients

    Seq Age Sex Outcome Treatment
    1