BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2753414 · Received September 20, 2012

    Report

    Report Number
    9611451-2012-00654
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 COMPLAINT HEAD WARMER ASSEMBLY WAS RECEIVED AT OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE IT WAS VISUALLY INSPECTED BY A TRAINED FPH SERVICE TECHNICIAN. THE DAMAGED COMPONENTS WERE THEN RETURNED TO FPH IN (B)(4) FOR FURTHER TESTING. RESULT: VISUAL INSPECTION REVEALED THAT THERE WERE MULTIPLE CRACKS AND SURFACE CRAZING ON THE DOME AND BOTH SIDES OF THE UPPER HEAD CASE. THE HEAD SURFACE WAS STICKY. A LATERAL CRACK ON THE SUPPORT ARM WAS IDENTIFIED. A BREAKAGE TEST COULD NOT REPLICATE THIS TYPE OF CRACK. THE UPPER HOUSING CONNECTORS WERE DISCOLOURED AND THE CERAMIC INSULATOR AND A SCREW BOSS WERE ALSO DAMAGED. A LOT CHECK REVEALED FIVE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030109. CONCLUSION: IT IS LIKELY THAT THE CRACKING AND CRAZING OF THE COMPLAINT WARMER HEAD 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 CRAZING AND CRACKING OF THE HEATER HEAD. THE COMPLAINT UNIT IS OVER NINE YEARS OLD. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNIT FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS THE 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. AS PART OF OUR CONTINUOUS IMPROVEMENT INITIATIVES THE MATERIAL USED TO MANUFACTURE THE HEAD WARMER ASSEMBLY WAS CHANGED TO ONE THAT OFFERS GREATER RESISTANCE TO ENVIRONMENTAL STRESS CRACKING. THE CERAMIC INSULATOR AND SCREW BOSS WERE MOST LIKELY DAMAGED BY SOME FORM OF IMPACT. THE IW910 MOBILE INFANT WARMER IS A MOBILE UNIT AND IS SUSCEPTABLE TO ACCIDENTAL IMPACT DAMAGE THROUGH COLLISIONS WITH WALLS OR SWINGING DOORS WHILE BEING TRANSPORTED. WE WERE UNABLE TO REPLICATE THE CRACK IDENTIFIED ON THE SUPPORTING ARM. THE CRACK WAS NOTED TO START FROM THE WELD LINE AND MAY HAVE BEEN INITIATED AS A RESULT OF A MOULDING DEFECT. THE UPPER AND LOWER HARNESSES ARE USED TO CONNECT THE HEAD UNIT TO THE CONTROL UNIT OF THE INFANT WARMER. THE DISCOLOURED HOUSING CONNECTOR WAS MOST LIKELY DUE TO ARCING THAT OCCURED BETWEEN TWO ELECTRICAL CONTACTS, LEADING TO CONTACT FAILURE. THE ARCING WAS PROBABLY CAUSED BY A POOR CONNECTION. 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. ALL THE DAMAGED COMPONENTS WERE REPLACED BY A TRAINED FPH TECHNICIAN AT OUR (B)(4) FACILITY AND THE HEAD WARMER ASSEMBLY WAS RETURNED TO THE CUSTOMER AFTER PERFORMING AN ELECTRICAL SAFETY AND PERFORMANCE CHECK.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT THE UPPER HEATER HEAD CASE ON AN IW910 MOBILE INFANT WARMER WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEATER HEAD CASE ON AN IW910 MOBILE INFANT WARMER WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW910 030109

    Patients

    Seq Age Sex Outcome Treatment
    1