BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2001350 · Received February 25, 2011

    Report

    Report Number
    9611451-2011-00092
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BD
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CASTOR FROM A PLASTIC BASE WAS RETURNED AND VISUALLY INSPECTED. IN ADDITION THE FOOT CLIP SECURITY PLATE WAS ALSO RETURNED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE THREADED BOLT STEAM OF THE COMPLAINT CASTOR HAD SNAPPED OFF AFTER THE LOCKING NUT. THE CORRESPONDING PIECE RECEIVED WAS 45 MM IN LENGTH AND PRESENTED WITH THE SAME STRESS MARKS AS THE OTHER PIECE. THE WHEELS WERE OBSERVED TO HAVE SOME FLAT SPOTS AND VARIOUS SCRATCHES ON IT. SOME DENTS WERE ALSO OBSERVED ON THE LEADING FRONT OF THE CASTOR POLYAMIDE BODY. THE VISUAL INSPECTION ALSO REVEALED A DENT ON THE RETURNED FOOT CLIP SECURITY PLATE, AND THAT IT WAS SLIGHTLY BENT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: BASED ON THE INSPECTION OF THE RETURNED COMPLAINT DEVICES, IT IS LIKELY THAT THE CASTOR HAD SHEARED OFF DUE TO IMPACT DAMAGE. THE DENTS OBSERVED ON THE CASTOR BODY AND THE BENT CLIP SECURITY PLATE IMPLIES THAT THE WHEEL HAS BEEN SUBJECTED TO SOME FORM OF IMPACT FORCE. THE MOBILE INFANT WARMER PROVIDES MOBILE WARMING WHEREVER NEEDED. IT CAN BE SUSCEPTIBLE TO IMPACT DAMAGE WHEN IT IS MOVED FROM ONE ROOM TO ANOTHER FOR VARIOUS REASONS, SUCH AS ACCIDENTAL BUMPS AND/OR COLLISIONS BETWEEN THE CASTOR WHEELS AND WALLS, UNEVEN SURFACES AND TRANSPORTING VIA ELEVATORS. THE LOT DATE INDICATES THAT THIS DEVICE IS SIX YEARS OLD ,AND THAT IT IS POSSIBLE FOR DYNAMIC STRESSES TO OCCUR AT THE BASE REGION OF INFANT WARMERS OVER A PERIOD OF TIME FROM A COMBINATION OF OVERLOADING AND TRANSPORT TO AND FROM DIFFERENT WARDS 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 METAL BASE HAS BEEN SUPPLIED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE REAR RIGHT CASTOR OF AN IW934 COSYCOT INFANT WARMER "FELL OFF" WHILE STEERING THE DEVICE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE REAR RIGHT CASTOR OF AN (B)(4) COSYCOT INFANT WARMER "FELL OFF" WHILE STEERING THE DEVICE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934JEU 050305

    Patients

    Seq Age Sex Outcome Treatment
    1