BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON SERIES CPAP

    MDR report key: 2490514 · Received March 13, 2012

    Report

    Report Number
    9611451-2012-00149
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K094040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT ICON CPAP AND THE RESMED MASK WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) FOR EVALUATION. THE UNIT WAS POWERED UP, INSPECTED AND THEN OPENED FOR FURTHER INVESTIGATION. SAMPLES OF THE BLACK 'DEPOSITS' WERE SENT TO THE (B)(6) FOR SURFACE AND MATERIALS SCIENCE FOR ANALYSIS. EXAMINATION OF DEVICES: WHEN POWER WAS APPLIED TO THE CPAP UNIT IT CAME ON IN STANDBY MODE BUT DID NOT RUN. WHEN THE WATER CHAMBER WAS INSPECTED, BLACK DUST WAS OBSERVED ON THE SILICONE PARTS, ABOUT THE CHAMBER BAFFLE AND IN THE BOTTOM OF THE CHAMBER. BLACK PARTICLES WERE ALSO PRESENT AT THE PATIENT END OF THE HEATED BREATHING TUBE AND ON THE NON RETURN VALVE FLAP ATTACHED TO THE INSIDE OF THE ELBOW. SMALL AMOUNTS OF THE BLACK MATERIAL COULD BE SEEN ON THE SILICONE SEAL OF THE MASK. A BURNT PLASTIC SMELL WAS OBSERVED ABOUT THE INSPECTED PARTS. THE UNIT WAS OPEN FOR INVESTIGATION. BLACK PARTICLES WERE OBSERVED ON THE FOAM PARTS IN THE AIR BOX. SIGNS OF WATER INGRESS WERE ALSO OBSERVED ABOUT THE FOAM AND THE AIR BOX WALLS. BLACK AND REDDISH PARTICLES WERE OBSERVED ON THE BOTTOM OF THE BLOWER MOTOR AND THE BASE. THE TOP BEARING OF THE BLOWER MOTOR WAS FOUND TO HAVE DISINTEGRATED AND WAS IN SEVERAL PIECES. OF THE EIGHT BALL BEARINGS USUALLY HELD IN THE BEARING HOUSING; ONLY TWO WERE SIGHTED. THE IMPELLOR HAD COME INTO CONTACT WITH THE BOTTOM COVER AND SOME OF ITS MASS HAD BEEN GROUND AWAY, LEAVING THE BLACK PARTICLES THAT WERE PROMINENT IN THE AIR PATH, ON THE FOAM, ON THE OUTLET ELBOW AND IN THE CHAMBER. BIOCOMPATIBILITY ASSESSMENT: THE AFFECTED COMPONENTS (IMPELLOR, WATER CHAMBER, HEATER BREATHING TUBE AND ELBOW) WERE SENT TO (B)(6) RESEARCH CENTRE FOR SURFACE AND MATERIALS SCIENCE FOR ANALYSIS OF THE BLACK PARTICLES. THE BLACK DUST CONTAINED PARTICLES FROM THE BLACK PLASTIC OF THE IMPELLOR (BRAND NAME NORYL) AND FROM THE BEARING. THESE PARTICLES WERE PRESENT IN THE AIR PATH. THE PLASTIC, NORYL, WAS BIOCOMPATIBILITY TESTED IN 2007 AND FOUND TO BE NON-TOXIC. A BIOCOMPATIBILITY ASSESSMENT OF THE BEARING COMPONENTS WAS PERFORMED BY (B)(6): ASSOCIATE PROFESSOR IN TOXICOLOGY, FROM THE DEPARTMENT OF PHARMACOLOGY & CLINICAL PHARMACOLOGY IN (B)(6). CONCLUSION: DR (B)(6) CONCLUDED IN HIS REPORT ON THE MAGNET PARTICLES THAT "SMALL EXPOSURE TO DUST FROM A METAL BEARING MAY PRODUCE SOME IRRITATION, BUT THERE IS NO EVIDENCE TO SUGGEST THAT SUCH EXPOSURE WOULD HAVE ANY CHEMICAL TOXICITY IN HUMANS AT THE LEVEL OF EXPOSURE". THE BEARING HAD DEGRADED AS A RESULT OF EXCESSIVE WATER INGRESS IN THE MOTOR. THE PRODUCT INFORMATION MANUAL WHICH ACCOMPANIES THE ICON STATES: "IF WATER DAMAGE OCCURS TO YOUR DEVICE, DISCONNECT THE POWER CORD, DISCONTINUE USE IMMEDIATELY AND SEEK ADVICE FROM YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    A HOME PATIENT IN (B)(6) REPORTED THAT WHILE USING AN ICON CPAP HUMIDIFIER AND A RESMED MIRAGE MICRO NASAL MASK SHE NOTICED A BURNING SMELL COMING FROM THE UNIT AND LATER NOTICED BLACK DEPOSITS IN THE CHAMBER, TUBE AND IN HER MASK. THE PATIENT DID NOT RECEIVE ANY INJURY RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON SERIES CPAP BZD BZD FISHER & PAYKEL HEALTHCARE LTD ICON 111117

    Patients

    Seq Age Sex Outcome Treatment
    1 RESMED MIRAGE MICRO NASAL MASK