BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1083137 · Received July 24, 2008

    Report

    Report Number
    9611451-2008-00477
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    July 8, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K970432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: AN INITIAL INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. RESULTS: 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 USING A MIXTURE OF PRECISE QTB, ALKYL DIMETHYL BENZYL, AMMONIUM CHLORIDE AND ETHYL BENZYL BENZOYL IN CLEANING THE INFANT WARMER HEAD. 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 C. THE DEVICE IS MADE UP OF POLYCARBONATE PLASTICS AND CLEANING SOLUTIONS CONTAINING AROMATIC HYDROCARBONS, AMMONIA, AMINES OR AQUEOUS SOLUTIONS ARE NOT RECOMMENDED AS THESE MAY CAUSE CHEMICAL REACTIONS TO THE 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 IN (B)(6) REPORTED THAT THEIR IW910JEU MOBILE INFANT WARMER HEAD HAD CRACKED AS THEY WERE USING THE WRONG CLEANING PRODUCT. THEY WERE USING A MIXTURE OF PRECISE QTB, ALKYL DIMETHYL BENZYL, AMMONIUM CHLORIDE AND ETHYL BENZYL BENZOYL IN CLEANING THE INFANT WARMER HEAD. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1