BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 2208518 · Received August 11, 2011

    Report

    Report Number
    9611451-2011-00483
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 20, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WARMER HEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER. IT HAS BEEN VISUALLY INSPECTED BY A FISHER & HEALTHCARE SERVICE PERSONNEL AT OUR REGIONAL OFFICE IN (B)(4). THE VISUAL INSPECTION CONFIRMED THE REPORTED FAULT OBSERVED BY THE CUSTOMER. MULTIPLE CRACKS AND CHIPS WERE FOUND ON THE SIDES OF THE UPPER MOLDED HEATER HEAD CASE. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT 020924. IT IS LIKELY THAT THE CRACKING OF THE COMPLAINT WARMER HEAD IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE (B)(4) 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 (B)(4) 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. THE COMPLAINT WARMER HEAD CASING HAS SINCE BEEN REPLACED WITH A NEW UPPER HEAD CASING AND RETURNED TO THE HEALTHCARE FACILITY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER HEAD OF AN (B)(4) BABY CONTROL COSYCOT INFANT WARMER WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1