BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 2351748 · Received November 29, 2011

    Report

    Report Number
    9611451-2011-00742
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    October 31, 2011
    Report Date
    November 2, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CRACKED HEATER HEAD OF IW930JEU BABY CONTROL COSYCOT INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HEAD ASSEMBLY OF THE IW930JEU BABY CONTROL COSYCOT INFANT WARMER WAS VISUALLY INSPECTED AT FISHER & PAYKEL SERVICE CENTRE IN (B)(4). RESULTS: VISUAL INSPECTION CONFIRMED THE FAULT OBSERVED BY THE HOSPITAL. FEW LARGE CRACKS WERE FOUND ON THE WARMER HEAD AND SOME SPATTERS ON THE REFLECTOR. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 030120. CONCLUSION: IT IS LIKELY THAT THE CRACKING 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 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, GLUTARALDEHYDE 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 HAS SINCE BEEN REPLACED WITH A NEW HEAD CASING AND RETURNED TO THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE KIT HEAD CASE REPLACEMENT OF IW930JEU BABY CONTROL COSYCOT INFANT WARMER WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE KIT HEAD CASE REPLACEMENT OF IW930JEU 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 LIMITED IW930JEU

    Patients

    Seq Age Sex Outcome Treatment
    1