BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALL MOUNT INFANT WARMER

    MDR report key: 2946865 · Received February 6, 2013

    Report

    Report Number
    9611451-2013-00076
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HEAD WARMER ASSEMBLY WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4) WHERE IT WAS VISUALLY EXAMINED BY A TRAINED FPH SERVICE ENGINEER. THE HEAD WARMER ASSEMBLY WAS REPAIRED AND THE FAULTY COMPONENTS WERE SENT TO FPH (B)(4) FOR FURTHER TESTING. RESULTS: VISUAL INSPECTION REVEALED SLIGHT DISCOLOURATION ON BOTH SIDES OF THE UPPER HEAD CASE. FURTHER INSPECTION IDENTIFIED CORROSION ON THE HEATING ELEMENT TERMINAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070108. CONCLUSION: THE CORROSION IDENTIFIED ON THE HEATING ELEMENT TERMINAL CONNECTOR WAS MOST LIKELY DUE TO A LOOSE CONNECTION AND WOULD HAVE GRADUALLY DEVELOPED OVER SEVERAL YEARS OF USE. THE COMPLAINT INFANT WARMER WAS SIX YEARS OLD. THE INFANT WARMER CONTROLLER CONTINUOUSLY MONITORS THE POWER SUPPLIED TO THE HEATING ELEMENT. WHEN INSUFFICIENT POWER IS NOTED, THE INFANT WARMER DISPLAYS THE ERROR 17 AND ENTERS A FAIL SAFE MODE WHERE THE POWER TO THE HEATING ELEMENT IS TERMINATED AND A VISUAL AND AUDIBLE ALARM IS GENERATED. IT IS MOST LIKELY THAT THE DISCOLOURATION OF THE UPPER HEAD CASE IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. 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. THE COMPLAINT HEAD WARMER ASSEMBLY WAS REPAIRED WITH A REPLACEMENT HEAD KIT AND A NEW HEATER ELEMENT. IT WAS RETURNED TO THE CUSTOMER AFTER PASSING THE NECESSARY SAFETY AND PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW980 WALL MOUNT INFANT WARMER HAS AN ERROR CODE AND HAS REQUESTED A SERVICE TO BE PERFORMED ON THE UNIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW980 WALL MOUNT INFANT WARMER HAS AN ERROR CODE AND HAS REQUESTED A SERVICE TO BE PERFORMED ON THE UNIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50062 WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW980 070108

    Patients

    Seq Age Sex Outcome Treatment
    1