BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2706823 · Received August 20, 2012

    Report

    Report Number
    9611451-2012-00562
    Event Type
    Malfunction
    Date Received
    August 20, 2012
    Report Date
    July 27, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 AND DEVICE MANUFACTURER DATES: 090224000308 - 24 FEBRUARY 2009; 081030001612 - 30 OCTOBER 2008; 090224000300 - 24 FEBRUARY 2009; 090224000306 - 24 FEBRUARY 2009; 090224000311 - 24 FEBRUARY 2009; 090224000305 - 24 FEBRUARY 2009; 030204000136 - 04 FEBRUARY 2003; 030129000120 - 29 JANUARY 2003; 030129000121 - 29 JANUARY 2003. THE COMPLAINT DEVICES ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH). THREE PHOTOGRAPHS OF THE COMPLAINT HEATER HEADS WERE PROVIDED TO US BY THE HOSPITAL. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL. THE PHOTOGRAPHS REVEALED CRACKING AND FLAKING OF THE PLASTIC ON THE UPPER HEATER HEAD CASINGS. CRAZING WAS ALSO OBSERVED ON THE DOME AREA OF THE UPPER HEAD. THE HOSPITAL REPORTED THAT "(B)(6)" MULTI SURFACE DETERGENT WIPES WERE USED TO CLEAN THE COMPLAINT DEVICES. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 090224, AND NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBERS 081030, 030204, AND 030129. CONCLUSION: THE CLEANING SOLUTION USED BY THE HOSPITAL, "CLINITEX", IS NOT A FPH RECOMMENDED CLEANING SOLUTION. THE CRACKING AND CRAZING OF THE COMPLAINT WARMER HEADS ARE MOST LIKELY 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 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 ON 2 JUNE 2010, WE CHANGED THE MATERIAL USED IN THE MANUFACTURE OF THE HEAD HOUSING TO ONE THAT OFFERS GREATER RESISTANCE TO ENVIRONMENTAL STRESS CRACKING. WE ALSO REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER HEADS OF 9 IW952 INFANT WARMERS WERE CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW952

    Patients

    Seq Age Sex Outcome Treatment
    1