BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP

    MDR report key: 1866169 · Received October 12, 2010

    Report

    Report Number
    9611451-2010-00613
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZD
    PMA / PMN Number
    K041900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FISHER & PAYKEL HEALTHCARE HC604 CPAP AND RESPIRONICS POWER CORD WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. THE CPAP AND POWER CORD WERE TESTED AS FOLLOWS: THE CPAP WAS TESTED FOR FUNCTIONALITY. A FISHER & PAYKEL HEALTHCARE POWER CORD WAS ATTACHED TO THE CPAP FOR TESTING. THE CPAP POWERED ON AND PASSED ALL FUNCTIONAL TESTS. THE CPAP WAS OPENED FOR INTERNAL INSPECTION. THERE WAS NO DAMAGE TO THE INTERNAL COMPONENTS OF THE CPAP. THE RESPIRONICS POWER CORD WAS VISUALLY INSPECTED FOR DAMAGE. THE END OF THE POWER CORD, WHERE IT ATTACHES TO THE CPAP, WAS BURNT. THE METAL WIRES AND PINS APPEARED TO HAVE BURNT COMPLETELY. NO FAULT WAS FOUND WITH THE FISHER & PAYKEL HEALTHCARE HC604 CPAP DEVICE AS IT OPERATED PROPERLY DURING TESTING AND SHOWED NO SIGNS OF INTERNAL DAMAGE. THE END OF THE RESPIRONICS POWER CORD WAS COMPLETELY BURNT. FISHER & PAYKEL HEALTHCARE SUSPECTS THAT THE FIRE WAS CAUSED BY THE CONNECTOR ON THE POWER CORD. AS FISHER & PAYKEL HEALTHCARE DOES NOT MANUFACTURE NOR SUPPLY THE COMPLAINT POWER CORD, WE ARE UNABLE TO COMMENT ON THE ROOT CAUSE OF THE FIRE. FISHER & PAYKEL HEALTHCARE HAS NOTIFIED THE DISTRIBUTOR OF THE POWER CORD, RESPIRONICS, INC., OF THIS PRODUCT COMPLAINT.

    Description of Event or Problem · 1

    A HOSPITAL MEDICAL SUPPLIER IN (B)(6) REPORTED THAT AN HC604 CPAP WAS PLUGGED INTO A POWER SOURCE AND THEN POWERED ON. WHEN THE UNIT WAS POWERED ON, THE PATIENT OBSERVED THAT THE POWER CORD WAS ON FIRE. THE COMPLAINANT REPORTED THAT THE PATIENT HAD BEEN USING A POWER CORD WHICH WAS SUPPLIED BY RESPIRONICS RATHER THE POWER CORD THAT WAS SUPPLIED WITH THE FISHER & PAYKEL HEALTHCARE CPAP MACHINE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP BZD BZD FISHER & PAYKEL HEALTHCARE LIMITED HC604JHU 070402

    Patients

    Seq Age Sex Outcome Treatment
    1 RESPIRONICS POWER CORD