BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1850801 · Received October 3, 2010

    Report

    Report Number
    9611451-2010-00595
    Event Type
    Malfunction
    Date Received
    October 3, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER.WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).METHOD: THE COMPLAINT INFANT WARMER BASE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S (B)(4). AN INVESTIGATION WAS CARRIED OUT BASED ON PHOTOGRAPHS OF THE DEVICE. RESULTS: THE PLASTIC ON THE BOTTOM EDGE OF ONE OF THE BASE LEGS WAS CHIPPED. THE OPPOSING LEG WAS ALSO FOUND TO BE DAMAGED. THE CIRCLIP PLATE FOR THE BASE FEET WAS OUT OF POSITION. THE CASTOR WAS FURTHER INSPECTED BY THE FISHER & PAYKEL HEALTHCARE SERVICE TECHNICIANS WHO ADVISED THAT THE WHEEL COULD BE ROTATED EVEN WHEN THE BRAKE WAS ENGAGED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 050406. CONCLUSION: THE DAMAGE TO THE TWO LEGS IS LIKELY TO HAVE BEEN CAUSED BY REPEATED IMPACT ON THE BASE DUE TO ROUGH HANDLING. THE IW932 IS A MOBILE WARMER AND CAN BE DAMAGED DURING TRANSPORT. IT IS POSSIBLE THAT THE BASE LEGS ENCOUNTERED ACCIDENTAL IMPACT THROUGH COLLISION WITH WALLS OR SWINGING DOORS. THIS DAMAGE IS LIKELY TO HAVE AFFECTED THE CASTOR AS WELL AND WOULD HAVE BEEN EXAGGERATED IF THE UNIT HAD BEEN WHEELED OVER UNEVEN FLOORS DURING ITS FIVE YEARS OF USAGE. A MISALIGNED CASTOR WILL BE EVIDENT TO THE USER AS THIS WILL RESULT ON STEERING PERFORMANCE ISSUE. THE PRODUCT TECHNICAL MANUAL ADVISES THAT THE CASTORS SHOULD BE CHECKED TO ENSURE THAT THEY ROLL AND LOCK PROPERLY AS PART OF THE ANNUAL FUNCTIONAL CHECK. A REPLACEMENT BASE ASSEMBLY HAS BEEN SUPPLIED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WHEEL ON AN IW932 COSYCOT INFANT WARMER BASE IS TILTED.THE TILTED WHEEL WAS FOUND BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WHEEL ON AN IW932 COSYCOT INFANT WARMER BASE IS TILTED. THE TILTED WHEEL WAS FOUND BY THE HOSPITAL PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW932JEU 050406

    Patients

    Seq Age Sex Outcome Treatment
    1