BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL CONTROLLED INFANT WARMER

    MDR report key: 2757008 · Received September 24, 2012

    Report

    Report Number
    9611451-2012-00668
    Event Type
    Malfunction
    Date Received
    September 24, 2012
    Report Date
    August 28, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: NO COMPLAINT DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THEREFORE OUR EVALUATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT THE HEATER HEAD IW990 INFANT WARMER UNIT WAS CRACKING. THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER REVEALED CRACKING ON THE DOME PORTION OF THE HEATER HEAD CASE, ALONG WITH CRAZING AND FLAKING OF PLASTIC SHELL ON THIS AREA. PLASTIC CHIPPING WAS OBSERVED AT THE BOTTOM EDGE OF THE UPPER HEAD CASE. THE HOSPITAL REPORTED THAT THEY USED "CLINITEX" AS THE CLEANING AGENT FOR THE INFANT WARMER UNITS. A LOT CHECK REVEALED 6 OTHER COMPLAINTS OF THIS TYPE FROM THE SAME HOSPITAL FOR LOT NUMBER 070130. CONCLUSION: THE CRAZING AND CRACKING OF THE COMPLAINT WARMER HEADS ARE RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. THE CLEANING AGENT USED BY THE HOSPITAL (CLINITEX), WHICH CONTAINS INGREDIENTS THAT ARE NOT RECOMMENDED BY FPH. WHEN THE HEATER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION CAN RESULT IN GRADUAL CRACKING AND CRAZING OF THE HEATER HEAD. CRAZING OR CRACKING USUALLY OCCURS AT THE AREAS WHERE INTERNAL STRESS HAS DEVELOPED DURING THE MOULDING OF THE HEAD CASE AND AGGRAVATION. THE INFANT WARMER SERVICE MANUAL 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. FPH REGIONAL OFFICE IN (B)(4) HAS SENT GUIDELINES ON HOW TO CLEAN THE PRODUCT AS PER THE IW900 TECHNICAL MANUAL. HEAD REPLACEMENT KIT WILL ALSO BE SENT TO THE HOSPITAL TO REPLACE THE DAMAGED HEATER HEAD.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN IW990 MANUAL CONTROLLED INFANT WARMER HAD CRACKING ON THE HEATER HEAD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL CONTROLLED INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW990

    Patients

    Seq Age Sex Outcome Treatment
    1