BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 3090861 · Received May 2, 2013

    Report

    Report Number
    9611451-2013-00353
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    March 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICE WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) US SERVICE CENTER IN (B)(4) WHERE IT WAS INSPECTED BY A TRAINED FPH SERVICE TECHNICIAN. THE FAULTY COMPONENTS FROM THE COMPLAINT DEVICE WAS RETURNED TO FPH (B)(4) FOR INVESTIGATION. RESULTS: THE ELECTRICAL RESISTANCE TEST OF THE HEATING ELEMENT REVEALED THAT THE HEATING ELEMENT WAS WITHIN SPECIFICATION. VISUAL INSPECTION OF THE WARMER HEAD HOUSING REVEALED THAT THERE WAS SLIGHT CRAZING ON THE UPPER HEAD CASE. THE HEAD WAS FOUND TO BE DISCOLORED, AND DIRT RESIDUE WAS EVIDENT AT THE TOP OF THE WARMER HEAD'S SURFACE. VISUAL INSPECTION OF THE UPPER HEAD HARNESS REVEALED THAT ONE OF THE TERMINAL CONNECTIONS WAS FOUND TO BE DAMAGED. 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 COMPLAINT UNIT IS OVER 6 YEARS OLD. 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, GLUTERALDEHYDE 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 E17 ERROR CODE OCCURED AS THERE WAS A DISCONTINUITY OF POWER TO THE HEATER ELEMENT. ONE OF THE TERMINAL CONNECTIONS FROM THE UPPER HARNESS TO THE HEATER ELEMENT WAS FOUND TO BE DAMAGED. THIS TERMINAL DAMAGE IS POSSIBLY CAUSED BY POOR CONNECTIONS BETWEEN TWO ELECTRICAL CONTACTS, LEADING TO CONTACT FAILURE. ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY UNDERWRITERS LABORATORIES (UL). SHOULD THE CONNECTORS COMPLETELY FAIL DURING THE OPERATION, AN AUDIBLE AND VISUAL ALARM WILL BE REGISTERED ON THE FRONT CONTROL PANEL OF THE INFANT WARMER, THEREBY ALLOWING THE HOSPITAL STAFF TIME TO ACT AND PROVIDE OTHER MEANS OF WARMING. THE DAMAGED COMPONENTS WERE REPLACED AND THE HEAD WARMER ASSEMBLY WAS RETURNED TO THE CUSTOMER AFTER PASSING THE ELECTRICAL SAFETY AND PERFORMANCE TESTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW910 MOBILE INFANT WARMER HAD AN E17 ERROR CODE. DURING SERVICING AT FISHER & PAYKEL HEALTHCARE REGIONAL OFFICE IN (B)(6), THE HEAD HARNESS WAS FOUND TO BE DISCOLORED. THIS COMPLAINT BECAME VIGILANCE REPORTABLE AS OF (B)(6) 2013. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191786 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW910 061019001197

    Patients

    Seq Age Sex Outcome Treatment
    1