BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 3057025 · Received April 14, 2013

    Report

    Report Number
    9611451-2013-00203
    Event Type
    Malfunction
    Date Received
    April 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HEAD WARMER ASSEMBLY OF THE COMPLAINT IW934 COSYCOT INFANT WARMER WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) WHERE IT WAS VISUALLY EXAMINED BY A TRAINED FPH SERVICE ENGINEER. THE FAULTY COMPONENTS WERE THEN SENT TO FPH IN (B)(4) FOR FURTHER INSPECTION. RESULTS: VISUAL INSPECTION REVEALED CHIPPING AND FLAKING ON THE BOTTOM EDGE OF THE UPPER HEAD CASE. CRAZING WAS NOTED ON THE DOME AREA AND THE HEAD LABEL WHERE STICKY DIRT RESIDUE WAS FOUND. THE UPPER HARNESS CONNECTOR WAS SLIGHTLY DISCOLOURED AND CORROSION WAS IDENTIFIED ON THE HEATING ELEMENT TERMINAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 060123. CONCLUSION: THE CORROSION IDENTIFIED ON THE HEATING ELEMENT TERMINAL CONNECTOR WAS MOST LIKELY DUE TO A LOOSE CONNECTION AND WOULD HAVE GRADUALLY DEVELOPED OVER SEVERAL YEARS OF USE. THE COMPLAINT INFANT WARMER WAS OVER SEVEN YEARS OLD. THE INFANT WARMER CONTROLLER CONTINUOUSLY MONITORS THE POWER SUPPLIED TO THE HEATING ELEMENT. WHEN INSUFFICIENT POWER IS NOTED, THE INFANT WARMER DISPLAYS THE ERROR 17 AND ENTERS A FAIL SAFE MODE WHERE THE POWER TO THE HEATING ELEMENT IS TERMINATED AND A VISUAL AND AUDIBLE ALARM IS GENERATED. THE UPPER AND LOWER HARNESSES ARE USED TO CONNECT THE HEAD UNIT TO THE CONTROL UNIT OF THE INFANT WARMER. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS REVEALED THAT THE DISCOLOURED HARNESS CONNECTORS OF THE INFANT WARMERS WERE MOST LIKELY THE RESULT OF ARCING THAT OCCURRED BETWEEN TWO ELECTRICAL CONTACTS, LEADING TO CONTACT FAILURE. ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY UNDERWRITERS LABORATORIES (UL). SHOULD THE CONNECTORS COMPLETELY FAIL DURING THE OPERATION, AN AUDIBLE AND VISUAL ALARM WILL BE REGISTERED ON THE FRONT CONTROL PANEL OF THE INFANT WARMER, THEREBY ALLOWING THE HOSPITAL STAFF TIME TO ACT AND PROVIDE OTHER MEANS OF WARMING. IT IS MOST LIKELY THAT THE CRACKING, CHIPPING AND FLAKING OBSERVED ON THE RETURNED HEATER HEAD WARMER 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. WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE DAMAGED COMPONENTS WERE REPLACED AND THE HEAD WARMER ASSEMBLY WAS RETURNED TO THE CUSTOMER AFTER PASSING THE ELECTRICAL SAFETY AND PERFORMANCE TESTS. PLEASE NOTE THAT THE DISCOLOURATION OF THE HEAD HARNESS CONNECTOR IS PART OF A CLASS III RECALL IN THE USA, WHEREBY ALL AFFECTED CUSTOMERS HAVE BEEN NOTIFIED TO CHECK FOR ANY DAMAGE OR DISCOLOURATION OF THE HARNESS CONNECTORS. IF DAMAGE OR DISCOLOURATION IS EVIDENT, CUSTOMERS HAVE BEEN ADVISED TO CONTACT A FPH REPRESENTATIVE TO OBTAIN REPLACEMENT HARNESS ASSEMBLIES.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW934 COSYCOT INFANT WARMER DISPLAYED AN E17 ERROR CODE AND THE HOSPITAL HAS REQUESTED A SERVICE. DURING THE SERVICE IT WAS IDENTIFIED THAT THE HEATER HEAD WAS CRACKED AND THE UPPER HARNESS CONNECTOR WAS DISCOLOURED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160086 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 060123

    Patients

    Seq Age Sex Outcome Treatment
    1