BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HC234 CPAP HUMIDIFIER

    MDR report key: 2100029 · Received May 24, 2011

    Report

    Report Number
    9611451-2011-00307
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K040941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED DEVICE WAS VISUALLY INSPECTED EXTERNALLY AND INTERNALLY FOR HEAT DAMAGE. THE UNIT WAS ALSO POWERED UP USING A NEW POWER CORD. RESULTS: EXTERNAL DAMAGE WAS OBSERVED ONLY ON THE POWER CORD CONNECTOR. THERE WAS EVIDENCE THAT THE POWER CORD CONNECTOR HAD OVERHEATED AT THE CRIMP LOCATION AND HENCE THE CONNECTOR OVERMOLD WAS DAMAGED AND PARTLY MELTED. THE UPPER AND LOWER CASES OF THE UNIT BY THE MAINS INLET SOCKET SHOWED NO SIGNS OF SMOKE DAMAGE. THE LOWER PIN OF THE MAINS INLET SOCKET WAS PUSHED IN, MAKING INTERMITTENT CONNECTION AND SIGNS OF ARCING WERE OBSERVED ON THE MAINS INLET PINS. BROWN STAINS AND DUST WERE OBSERVED AROUND THE HEATER PLATE, INSIDE THE AIR BOX AND FOAMS WHICH IS DUE TO NORMAL USE. THE ENCLOSURE AROUND THE PCB BOARDS WAS INSPECTED AND NO STAIN OR SMOKE DAMAGE WAS OBSERVED. THE UNIT STARTED AND WORKED NORMALLY WITH THE NEW POWER CORD. CONCLUSION: THE MANUFACTURER OF THE POWER CORD CONCLUDED IN THEIR INVESTIGATION REPORT THAT PROLONGED BENDING OF THE LEAD HAD CAUSED THE FAILURE AT THE PLUG. THIS PROLONGED BENDING STRESSED THE WIRE STRANDS AT THE CRIMPED JOINT, CAUSING THEM TO BREAK GRADUALLY AND FINALLY RESULTED IN ARCING THAT MELTED THE COPPER STRANDS AS WELL AS THE PVC OVER-MOLDING. THE HC234 IS DESIGNED TO THE ELECTRICAL SAFETY STANDARD, IEC 60601-1. THE MATERIALS USED IN THE THERMOPLASTIC COMPONENTS OF THE MAINS CONNECTOR AND THE CASES ARE FLAME RETARDANT ACCORDING TO IEC 60601-1. OUR EQUIVALENT PRODUCT IN THE U.S. IS DESIGNED TO THE STANDARD, UL60601-1, FOR BOTH HC234 AND POWER CORD. FISHER & PAYKEL HEALTHCARE IS CURRENTLY CONDUCTING A RETAIL LEVEL RECALL ON ALL VOLEX POWER CORDS USED IN THE HC230, HC240, HC250 AND HC600 SERIES CPAP HUMIDIFIERS IN (B)(4) AND (B)(4). CPAP HUMIDIFIERS MANUFACTURED SINCE JANUARY 2010 FEATURE A DIFFERENT, MORE ROBUST POWER CORD AND ARE NOT SUBJECT TO THIS RECALL. THE POWER CORD USED IN THE USA IS OF A DIFFERENT BRAND AND CONSTRUCTION AND IS NOT SUBJECT TO THIS RECALL.

    Description of Event or Problem · 1

    A HOME PATIENT REPORTED VIA HER SLEEP LABORATORY IN (B)(6) THAT THE POWER CORD HAD BURNT THROUGH ON HER HC234 CPAP HUMIDIFIER. THE PATIENT FURTHER REPORTED THAT SHE AWOKE TO SEE SPARKS COMING FROM THE POWER CORD. THERE WAS NO DAMAGE TO PROPERTY OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HC234 CPAP HUMIDIFIER BZD BZD FISHER & PAYKEL HEALTHCARE LTD HC234 060531

    Patients

    Seq Age Sex Outcome Treatment
    1