BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 4050265 · Received September 1, 2014

    Report

    Report Number
    9611451-2014-00741
    Event Type
    Malfunction
    Date Received
    September 1, 2014
    Report Date
    August 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HOSPITAL HAD REQUESTED A REPAIR OF THE IW950 INFANT WARMER. THE REPAIR WAS PERFORMED AT THE HOSPITAL PREMISES BY A TRAINED FISHER & PAYKEL HEALTHCARE TECHNICIAN. A REPORT AND SKETCH OF THE HEATER HEAD DAMAGE WAS PROVIDED FOR OUR INVESTIGATION. RESULTS: VISUAL INSPECTION OF THE PICTORIAL DIAGRAM PROVIDED BY THE UK SERVICE TECHNICIAN SHOWED THE PRESENCE OF MULTIPLE CRACK LINES ON THE DOME AND PLASTIC CHIPPING ON THE SIDE BOTTOM EDGE OF THE UPPER HOUSING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 040327. 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 WE WERE INFORMED THAT THE HEATER HEAD CRACKING ON THE LOWER SIDES WAS DUE TO SWINGING THE HEATER HEAD AGAINST THE MOUNTING POLE BRACKET. 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, GLUTERALDEHYDE 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 2 JUNE 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 HOSPITAL IN THE (B)(6) REQUESTED A SERVICE FOR AN IW950 COSYCOT INFANT WARMER AND STATED THAT THE HEATER HEAD WAS BROKEN.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531678 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW950 040327

    Patients

    Seq Age Sex Outcome Treatment
    1