BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 3490403 · Received November 26, 2013

    Report

    Report Number
    9611451-2013-00952
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Report Date
    October 28, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEFECTIVE WARMER HEAD ASSEMBLY OF THE IW930JEU BABY CONTROL COSYCOT INFANT WARMER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR ANALYSIS IS ACCORDINGLY BASED ON PHOTOGRAPHS PROVIDED BY THE CUSTOMER. RESULTS: PHOTOGRAPHS SHOWED THAT THE WARMER HEAD ASSEMBLY WAS CRACKED. CRAZING AND SMALL CRACKS WERE FOUND ON THE SURFACE OF THE UPPER HEAD CASING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030905. 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."

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ATTEMPTING TO RETRIEVE THE COMPLAINT DEVICE. WE WILL SEND A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED THAT THE UPPER HEAD CASING OF AN IW930 BABY CONTROL COSYCOT INFANT WARMER HAD CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED THAT THE UPPER HEAD CASING OF AN IW930 BABY CONTROL COSYCOT INFANT WARMER HAD CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615011 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW930

    Patients

    Seq Age Sex Outcome Treatment
    1