BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP HUMIDIFIER

    MDR report key: 2250548 · Received September 16, 2011

    Report

    Report Number
    9611451-2011-00579
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K040941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND THE DEVICE INVESTIGATION IS IN PROCESS. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HC234 CPAP DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE COMPLAINT POWER CORD WAS NOT THE FPH POWER CORD THAT IS SUPPLIED WITH THE PRODUCT. THE UNIT-END CONNECTOR OF THE POWER CORD WAS MISSING, AS IT APPEARED TO HAVE MELTED. THERE WAS A HOLE ON THE UNIT'S CASING, MEASURING 60 MM BY 100 MM, WHICH EXPOSED THE POWER PCB. INTERNAL INSPECTION OF THE UNIT REVEALED THAT CHARRING AND COMPONENT DAMAGE WAS FOUND ON THE POWER PCB, AROUND THE MAINS SOCKET. THE UNIT'S CASE IS COMPOSED OF A FLAME RETARDANT WITH (B)(4) AND IT PERFORMED AS INTENDED. THE HC230 PRODUCT IS DESIGNED TO THE ELECTRICAL SAFETY STANDARD (B)(4). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 051006. CONCLUSION: THE EXTENSIVE DAMAGE ON THE UPPER AND LOWER CASE APPEARED TO HAVE BEEN CAUSED BY LOCALIZED BURNING IN THE AREA OF THE POWER PCB. THE ROOT CAUSE OF THE "SPARK" IS OVERHEATING AT THE LOCATION WHERE THE MAINS CONNECTOR IS SOLDERED ONTO THE POWER PCB. OUR CAPA TO ADDRESS THIS ISSUE WAS COMPLETED AND AN ACTION HAS BEEN TAKEN AS A RESULT. A CHANGE IN THE PCB DESIGN WAS IMPLEMENTED IN (B)(4) 2009 AND INVOLVED THE ADDITION OF TRACKS AROUND THE MAINS CONNECTOR OF THE PCB. THE PCB WAS MODIFIED TO ENSURE THAT THERE ARE TRACKS ON BOTH SIDES OF THE PCB TO ALLOW THE SOLDERED SIDE TO CARRY THE MAJORITY OF THE DEVICE CURRENT. WE DID NOT RECEIVED ANY OTHER COMPLAINTS OF THIS TYPE FOR ALL UNITS MANUFACTURED AFTER THE CAPA IMPLEMENTATION. THIS COMPLAINT DEVICE DID NOT HAVE THE REVISED PCB AS IT WAS MANUFACTURED IN OCTOBER 2005. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE HC234 CPAP UNIT SPARKED WHERE THE POWER CORD CONNECTS TO THE MACHINE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE HC234 CPAP UNIT SPARKED WHERE THE POWER CORD CONNECTS TO THE MACHINE. 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 HC234

    Patients

    Seq Age Sex Outcome Treatment
    1