BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2618806 · Received June 17, 2012

    Report

    Report Number
    9611451-2012-00394
    Event Type
    Malfunction
    Date Received
    June 17, 2012
    Date of Event
    May 18, 2012
    Report Date
    May 23, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WARMER HEAD OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEFECTIVE WARMER HEAD ASSEMBLY OF THE IW910JEU BABY CONTROL MOBILE INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4). OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT AND PHOTOGRAPHS PROVIDED BY OUR SERVICE CENTRE. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED REVEALED THAT THE UPPER HEAD CASE SUSTAINED CRACKS. SOME YELLOWISH RESIDUES WERE ALSO NOTED ON THE CRACKED AREAS. ANOTHER CRACK WAS ALSO OBSERVED AT THE CLIP TAB ALONG THE GRILL OF THE LOWER CASE. THERE WAS ALSO EVIDENCE OF FLAKING AND CHIPPING OF THE PLASTIC SURFACE AT THE BOTTOM EDGE OF THE UPPER CASING. IT WAS ALSO STATED IN THE SERVICE REPORT THAT WHEN OUR SERVICE CENTRE RECEIVED THE DEFECTIVE WARMER HEAD ASSEMBLY, THE HEAD GRILL WAS FOUND DISLODGED FROM THE LOWER CASE FRAME AND THE LIGHT BOX WAS HANGING. NO OTHER PHYSICAL DAMAGE WAS OBSERVED TO THESE TWO COMPONENTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 071029. CONCLUSION: IT IS LIKELY THAT THE CRACKING OBSERVED ON THE UPPER AND LOWER HEAD CASINGS 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 DAMAGES OBSERVED ON THE HEAD GRILL AND LIGHT BOX COULD BE DUE TO IMPACT DAMAGE. THE IW910 INFANT WARMER IS A MOBILE UNIT THAT CAN BE MOVED FROM ONE LOCATION TO ANOTHER. IT IS POSSIBLE FOR THE WARMER HEAD ASSEMBLY TO INCUR ACCIDENTAL IMPACT DAMAGE THROUGH COLLISION WITH WALLS OR SWINGING DOORS DURING TRANSPORT AS THE WARMER HEAD CAN BE SWIVELLED BY ABOUT 130 DEGREES FROM ITS CENTRE POSITION. THE COMPLAINT WARMER HEAD ASSEMBLY HAS SINCE BEEN REPAIRED AND RETURNED TO THE HEALTHCARE FACILITY AFTER IT PASSED THE PERFORMANCE AND ELECTRICAL SAFETY TESTS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE LOWER HOUSING, LIGHT AND GRILL OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER WERE BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE LOWER HOUSING, LIGHT AND GRILL OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER WERE BROKEN AND "HANGING". 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 LIMITED IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1