BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1038425 · Received May 5, 2008

    Report

    Report Number
    9611451-2008-00269
    Event Type
    Malfunction
    Date Received
    May 5, 2008
    Date of Event
    September 9, 2007
    Report Date
    September 10, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING DATES: 09/14/2005, 09/14/2005. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION, PHOTOS AND RESULTS OF PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. CRACKING OF THE INFANT WARMER HEAD IS USUALLY DUE TO THE USE OF INCOMPATIBLE CLEANING SOLUTIONS AND DOING THE CLEANING BEFORE THE WARMER HEAD HAS BEEN COOLED. IT WAS REPORTED THAT THE HOSPITAL WAS COOLING THE WARMER HEADS BEFORE DOING THE CLEANING. FOR CLEANING AND DISINFECTING, THEY WERE USING INCIDIN FOAM, WHICH IS AN ALCOHOLIC DISINFECTANT CONTAINING GLUCOPROTAMIN. THE LATTER IS AN ANTIMICROBIAL INGREDIENT, WHICH IS REPORTED TO HAVE CONTAINED AMINE. THE OPERATING MANUAL STATES THAT CLEANING OF ALL PARTS OF THE INFANT WARMER AND ACCESSORIES SHOULD BE DONE AT NORMAL ROOM TEMPERATURE, AROUND 23 DEGREES CELSIUS, AND TO AVOID CLEANING SOLUTIONS CONTAINING AROMATIC HYDROCARBONS, AMMONIA, AMINES OR AQUEOUS SOLUTIONS AS THESE MAY CAUSE CHEMICAL REACTIONS TO THE POLYCARBONATE PLASTIC MATERIAL. ALL SURFACES OF THE WARMER HEAD MAY BE CLEANED WITH DETERGENT BASED SOLUTION WITH MAXIMUM CONCENTRATION OF 2% IN WATER. CONCLUSION: CRACKING OF THE INFANT WARMER HEAD, DUE TO THE USE OF NON-COMPATIBLE CLEANING MATERIALS, IS A KNOWN PROBLEM. WE HAVE AN OPEN CAPA TO EXAMINE FURTHER COMPATIBLE CLEANING SOLUTIONS.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THREE IW931 COSYCOT INFANT WARMER HEADS WERE FOUND TO HAVE CRACKS ON THE UPPER CASING. THE CRACKS WERE LOCATED IN THE SAME AREA OF THE WARMER HEADS, WITH ONE UNIT HAVING DEEPER CRACKS COMPARED TO THE OTHER TWO. IT WAS ALSO SPECIFIED THAT THE HOSPITAL WAS USING INCIDIN FOAM FOR CLEANING AND DISINFECTING THE WARMERS. FURTHERMORE, THEY WERE CLAIMING THAT CLEANING WAS BEING DONE ONLY AFTER THE UNITS HAD BEEN COOLED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD IW931

    Patients

    Seq Age Sex Outcome Treatment
    1