BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 4424491 · Received January 15, 2015

    Report

    Report Number
    9611451-2015-00023
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Report Date
    December 18, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL REPORTED THAT THE BOTTOM AND TOP OF THE HEATER HEAD CASE WAS CRACKED. THE SUBJECT INFANT WARMER WAS RELEASED FOR DISTRIBUTION IN 2007 AND IS SEVEN YEARS OLD. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 070410. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR PHOTOGRAPHS OF THE REPORTED DAMAGE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED CRACKING. IT IS LIKELY THAT THE REPORTED CRACKING 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. THE INFANT WARMER SERVICE MANUAL FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: THE PLASTIC SURFACES HIGHLIGHTED IN BLACK CONTAIN PLASTIC COMPONENTS MADE FROM POLYCARBONATE OR ACRYLIC, AND INCLUDE THE ENTIRE HEATER ASSEMBLY, BASSINET SIDE PANELS, COLUMN CAP AND FRONT PANEL FASCIAS; 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. OUR CLEANING INSTRUCTIONS RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES THAT CAN BE USED TO CLEAN THE FRONT PANEL FASCIAS AND OTHER WARMER COMPONENTS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT THE HEATER HEAD CASE OF AN IW934 COSYCOT INFANT WARMER WAS CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT THE HEATER HEAD CASE OF AN IW934 COSYCOT INFANT WARMER WAS CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38308 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 070410

    Patients

    Seq Age Sex Outcome Treatment
    1