BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALL MOUNT INFANT WARMER

    MDR report key: 2250551 · Received September 16, 2011

    Report

    Report Number
    9611451-2011-00578
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAD BEEN RECENTLY SERVICED BY AN FPH TECHNICIAN IN THE US REGIONAL OFFICE. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT IW980 WALL MOUNT INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE SERVICE CENTER IN (B)(4) FOR REPAIR. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WERE CRACKS AT THE CORNERS OF THE CONTROL PANEL AND ON THE UPPER CASE OF THE WARMER HEAD. UNIT WAS DISPLAYING AN E17 ERROR CODE WHEN UNIT WAS POWERED ON AND THE CAUSE OF THE E17 ERROR CODE WAS ISOLATED TO THE HEATING ELEMENT. A LOT CHECK REVEALED ONE OTHER E17 COMPLAINT AND TWO OTHER HEAD CRACKS COMPLAINTS OF THIS TYPE FOR LOT 031031. CONCLUSION: IT IS LIKELY THAT THE FLAKING AND CRACKING 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 CRACKING AND CRAZING OF THE HEATER HEAD. THE E17 ERROR CODE WAS CAUSED BY AN OPEN CIRCUIT OF THE HEATING ELEMENT. 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. THE COMPLAINT HEATING ELEMENT WAS REPLACED, BUT THE COMPLAINT WARMER HEAD CASING WAS NOT REPLACED AS PER THE CUSTOMER'S REQUEST. THE COMPLAINT DEVICE WAS RETURNED TO THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW980 WALL MOUNT INFANT WARMER WAS DISPLAYING AN E17 ERROR CODE AFTER THE CONTROL PCB WAS REPLACED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE IW980 WALL MOUNT INFANT WARMER WAS DISPLAYING AN E17 ERROR CODE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW980

    Patients

    Seq Age Sex Outcome Treatment
    1