BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 3901493 · Received June 30, 2014

    Report

    Report Number
    9611451-2014-00572
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE PIVOT SECURING NUT OF THE IW910 MOBILE INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. RESULTS: THE PIVOT SECURING NUT WAS FOUND TO BE BROKEN INTO TWO PIECES. THE HOSPITAL REPORTED THAT THE WARMER WAS NOT IN USE WHEN THIS FAILURE OCCURRED. CONCLUSION: THE INFANT WARMER HEAD IS ASSEMBLED ONTO THE WARMER COLUMN AT THE HOSPITAL. TO SECURE THE HEAD A PIVOT WASHER, PIVOT SECURING NUT AND LOCKING GLUE ARE APPLIED AS PER FPH'S INSTALLATION INSTRUCTIONS. THE IW900 SERIES SERVICE MANUAL RECOMMENDS FUNCTIONAL CHECK OF THE HEATER HEAD: "AT LEAST ANNUALLY CHECK THE HEATER HEAD SWIVEL IS SECURE." "ENSURE THE HEAD PIVOT NUT IS LOCKED/GLUED IN PLACE. CHECK THE SWIVEL MOVEMENT OF HEAD IS FREE AND THAT THE CENTRAL DETENTE CAN BE FELT."

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT INFANT WARMER HEAD HOUSING WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED MULTIPLE CRACK LINES AT THE DOME PORTION OF THE UPPER HEAD CASE. DELAMINATION OF THE OUTER PLASTIC SHELL AND SURFACE CRAZING WERE ALSO EVIDENT IN THIS AREA. CONCLUSION: IT IS LIKELY THAT THE PHYSICAL DAMAGE 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 INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNIT FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS THE POLYCARBONATE & 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." THE HOSPITAL REINSTALLED THE WARMER HEAD CORRECTLY AND THE WARMER WAS THEN PUT BACK INTO SERVICE AFTER PASSING THE REQUIRED ELECTRICAL SAFETY TESTS.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6), REPORTED THAT THE PIVOT SECURING NUT OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER WAS BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT THE UPPER HEAD CASING OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379183 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU 030516

    Patients

    Seq Age Sex Outcome Treatment
    1