BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON SERIES CPAP

    MDR report key: 4533695 · Received February 22, 2015

    Report

    Report Number
    9611451-2015-00096
    Event Type
    Malfunction
    Date Received
    February 22, 2015
    Report Date
    January 26, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K094040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT ICON CPAP WAS RECEIVED IN A PLASTIC BAG AT FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE ICON CPAP WAS INSPECTED EXTERNALLY. RESULTS: THE VISUAL INSPECTION REVEALED NO SIGNS OF IMPACT DAMAGE TO THE RETURNED CPAP. THE POWER CORD WAS DAMAGED APPROXIMATELY 100MM TOWARDS THE PLUG END AND THE PHASE CONDUCTOR WAS SEVERED AND EXPOSED. ADDITIONALLY, THE BLOWER SHOWED WATER INGRESS. THE TRANSPORT PLASTIC BAG HAD EXCESSIVE WATER CONTENT. DUE TO THE NATURE OF THE COMPLAINT AND THE WATER INGRESS, A PERFORMANCE TEST WAS NOT CARRIED OUT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF WATER INGRESS INTO THE BLOWER AND NO OTHER COMPLAINTS OF DAMAGED POWER CORDS FOR LOT NUMBER 120302. CONCLUSION: THE INVESTIGATED POWER CORD DAMAGE, AND OUR EXPERIENCE WITH THIS TYPE OF INCIDENT, SUGGESTS THAT PROLONGED BENDING STRESSED THE WIRE STRANDS IN THE POWER CORD. THIS CAUSED THE WIRE STRANDS TO BREAK GRADUALLY AND FINALLY RESULTED IN ARCING THAT MELTED THE COPPER STRANDS AS WELL AS THE PVC OVER-MOULDING. BASED ON THE GENERAL CONDITION OF THE UNIT AND POWER CORD, IT APPEARS THAT THE DEVICE HAD BEEN POORLY MAINTAINED. THE ICON CPAP IS DESIGNED TO THE ELECTRICAL SAFETY STANDARD, AS/NZS 3200.1. THE MATERIALS USED IN THE THERMOPLASTIC COMPONENTS OF THE MAINS CONNECTOR AND THE CASES ARE FLAME RETARDANT ACCORDING TO AS/NZS 3200.1. OUR EQUIVALENT PRODUCT IN THE US IS DESIGNED TO THE STANDARD, UL60601-1, FOR BOTH ICON AND POWER CORD. OUR USER INSTRUCTIONS THAT ACCOMPANY THE ICON STATE THE FOLLOWING: ONLY OPERATE IF THE DEVICE, POWER CORD AND PLUG ARE DRY AND IN GOOD WORKING ORDER. IF WATER DAMAGE OCCURS TO YOUR DEVICE, DISCONNECT THE POWER CORD, DISCONTINUE USE IMMEDIATELY AND SEEK ADVICE FROM YOUR HEALTHCARE PROVIDER. DO NOT STORE OR USE THE DEVICE WHERE IT CAN BE PULLED INTO WATER. DO NOT OPERATE THE DEVICE, WATER CHAMBER OR BREATHING TUBE IF IT IS DROPPED, DAMAGED OR NOT WORKING AS INTENDED. DO NOT MOVE, CARRY, TRANSPORT OR STORE THE DEVICE WITH WATER IN THE WATER CHAMBER.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE POWER CORD OF AN ICON CPAP HUMIDIFIER WAS FRAYED AND SPARKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124837 ICON SERIES CPAP BZD BZD FISHER & PAYKEL HEALTHCARE LTD ICONNAN 120302

    Patients

    Seq Age Sex Outcome Treatment
    1