BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 2143589 · Received June 29, 2011

    Report

    Report Number
    9611451-2011-00378
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    May 31, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBERS/DEVICE MANUFACTURE DATES: (B)(4) - 06/14/2004; (B)(4) - 06/14/2004; (B)(4) - 07/01/2004. METHOD: THE AFFECTED HEATER HEAD ASSEMBLIES ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) FOR INSPECTION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE PHOTOGRAPHS AND ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL, AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. FPH ALSO REQUESTED SPECIFIC DETAILS OF THE TYPE OF CLEANING SOLUTIONS ROUTINELY USED BY THE HOSPITAL TO CLEAN AND DISINFECT THE SURFACES OF THE INFANT WARMERS. RESULTS: THE PHOTOGRAPHS PROVIDED BY THE HOSPITAL REVEALED THAT THE BOTTOM EDGE OF THE UPPER HEAD CASE OF EACH HEATER HEAD ASSEMBLY WAS DELAMINATING AND CHIPPING. THE HOSPITAL REPORTED THAT HOSPEC NEUTRAL LIQUID DETERGENT, WHICH CONTAINS SODIUM LAURYL SULFATE, WAS BEING USED TO CLEAN THE SURFACES OF THE AFFECTED INFANT WARMERS. CONCLUSION: THE DAMAGE TO THE HEATER HEAD ASSEMBLIES IS CONSISTENT WITH DAMAGE CAUSED BY INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNITS 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 FOR INFANT WARMERS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER HEAD ASSEMBLIES OF THREE IW930AEK BABY CONTROL COSYCOT INFANT WARMER UNITS WERE FOUND CRACKED DURING USE. 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 IW930AEK

    Patients

    Seq Age Sex Outcome Treatment
    1