BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP

    MDR report key: 1231169 · Received November 12, 2008

    Report

    Report Number
    9611451-2008-00661
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Report Date
    October 15, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). METHOD: THE COMPLAINT DEVICE WAS VISUALLY INSPECTED. RESULTS: A HOLE WAS FOUND ON THE EXTERNAL CASING OF THE DEVICE. WATER INGRESS WAS FOUND IN AND AROUND THE BOTTOM ENCLOSURE GROOVE THAT SUPPORTS THE POWER ELECTRICAL PRINTED CIRCUIT BOARD (PCB). THE COMPONENTS AROUND THE PCB WERE CORRODED. THE FOAM WAS STILL WET AND WATER WAS VISIBLE ON THE POTTING MIX OF THE MOTOR. THE POWER PCB HAD EXTENSIVE DAMAGE FROM THE ARCING. LOCALISED HEATING CAUSED THE SMALL ENCLOSURE HOLE. THIS IS THE ONLY COMPLAINT OF THIS TYPE FOR THIS LOT NUMBER. THE HC604 IS DESIGNED TO THE ELECTRICAL SAFETY STANDARD (B) (4). CONCLUSION: WATER INGRESS IS MOST LIKELY THE CAUSE OF THE FAILURE. THE RESULTING RUST WOULD HAVE CREATED AN ELECTRICAL ARC BETWEEN TWO DIFFERENT VOLTAGE RAILS, CAUSING THE DEVICE TO STOP FUNCTIONING. 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 OVERMOLD PLASTIC MATERIAL (B) (4) 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. (B) (4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B) (4), REPORTED TO OUR USA OFFICE THAT AN HC604 CPAP HUMIDIFIER WOULD NOT TURN ON. UPON INSPECTION BY THE MANUFACTURER, NOTICEABLE HEAT DAMAGE WAS FOUND. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP BZD FISHER & PAYKEL HEALTHCARE, LTD. HC604 070616

    Patients

    Seq Age Sex Outcome Treatment
    1