BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 2829224 · Received November 12, 2012

    Report

    Report Number
    9611451-2012-00809
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBERS: (B)(4); LOT NUMBERS: 040517, 040517; DEVICE MANUFACTURER DATE: 05/17/2004, 05/17/2004. METHOD: THE COMPLAINT WARMER HEADS WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF PHOTOGRAPHS PROVIDED BY THE CUSTOMER WAS PERFORMED. RESULTS: THE PHOTOGRAPH INSPECTION REVEALED CRACKS ON THE DOME PORTION OF THE WARMER HEAD. CRAZING AND FLAKING OF THE PLASTIC SHELL WAS APPARENT AND CRACKS COULD BE SEEN IN THE MIDDLE OF THE SIDES OF THE UPPER CASE OF THE WARMER HEAD. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 040517. CONCLUSION: IT IS LIKELY THAT THE CRACKING AND CRAZING OBSERVED ON THE WARMER HEAD ASSEMBLY ARE RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. WHEN THE WARMER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE WARMER HEAD. 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 CONTINUOUS IMPROVEMENT, WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBERS: (B)(4); LOT NUMBERS: 040517, 040517; DEVICE MANUFACTURER DATE: 05/17/2004, 05/17/2004. THE COMPLAINT DEVICES ARE NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER. AN EVALUATION BASED ON THE INFORMATION RECEIVED IS ANTICIPATED. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEATER HEAD CASE OF TWO IW930 BABY CONTROL COSYCOT INFANT WARMERS WERE CRACKED. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEATER HEAD CASE OF TWO IW930 BABY CONTROL COSYCOT INFANT WARMERS WERE CRACKED. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW930 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1