BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 3914703 · Received July 3, 2014

    Report

    Report Number
    9611451-2014-00599
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT IW933 WARMER HEAD ASSEMBLY WAS SERVICED BY A CONTRACTOR IN (B)(4). PHOTOGRAPHS OF THE COMPLAINT HEATER HEAD WERE REQUESTED BUT WERE NOT PROVIDED TO US.OUR INVESTIGATION IS THEREFORE BASED ON OUR KNOWLEDGE OF THE PRODUCT. RESULTS: WE WERE INFORMED THAT THE UPPER HEAD CASE OF THE INFANT WARMER WAS CRACKED, BUT NO FURTHER DETAILS WERE PROVIDED. CONCLUSION: IT IS LIKELY THAT THE CRACKING AND CRAZING OF THE COMPLAINT WARMER HEAD IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. WHEN THE HEATER HEAD BEGINS TO WARM UP DURING USE A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE HEATER HEAD. IT MUST BE NOTED THAT THE COMPLAINT UNIT IS OVER 10 YEARS OLD AND THUS THE CRACKING COULD ALSO BE THE RESULT OF IMPACT DAMAGE AND WEAR AND TEAR WHILE MOVING THE WARMER BETWEEN WARDS. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNIT FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYPOCHLORITES, PEROXIDES, GLUTARALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE; CAUTION THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES. AS PART OF OUR CONTINUOUS IMPROVEMENT INITIATIVES ON (B)(4) 2010 WE CHANGED THE MATERIAL USED IN THE MANUFACTURE OF THE HEAD HOUSING TO ONE THAT OFFERS GREATER RESISTANCE TO ENVIRONMENTAL STRESS CRACKING. WE ALSO REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE COMPLAINT INFANT WARMER WAS REPAIRED AND RETURNED TO THE CUSTOMER FOLLOWING AN ELECTRICAL SAFETY AND PERFORMANCE CHECK.

    Description of Event or Problem · 1

    A SERVICING CONTRACTOR REPORTED THAT WHILE SERVICING AN IW933 COSYCOT INFANT WARMER FROM A HOSPITAL IN (B)(6) THEY FOUND THAT THE UPPER HEATER HEAD CASE WAS CRACKED. THIS WAS FOUND DURING SERVICING AND NOT WHILE IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391437 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW933 040622

    Patients

    Seq Age Sex Outcome Treatment
    1