BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 4837293 · Received June 11, 2015

    Report

    Report Number
    9611451-2015-00281
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 13, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE CUSTOMER. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HEAD WARMER ASSEMBLY OF THE COMPLAINT IW934 COSYCOT INFANT WARMER WAS RETURNED TO OUR SERVICE CENTER IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS AND SERVICE REPORT PROVIDED AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS REVEALED CRACKED LINES AT THE DOME PORTION OF THE HEAD WARMER ASSEMBLY. SURFACE CRAZING WAS ALSO EVIDENT IN THIS AREA. DELAMINATION OF THE OUTER PLASTIC SHELL AND PLASTIC CHIPPING WAS EVIDENT AT THE BOTTOM EDGE OF THE UPPERCASE OF THE HEAD WARMER. THE SCREW BOSS ON THE UPPER CASE WAS ALSO BROKEN. A LOT CHECK REVEALED THREE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 051029. THE SUBJECT INFANT WARMER WAS RELEASED FOR DISTRIBUTION ON 4 NOVEMBER 2005 AND IS THUS ALREADY A NINE YEAR OLD UNIT. 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 INFANT WARMER SERVICE MANUAL FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: THE PLASTIC SURFACES HIGHLIGHTED IN BLACK CONTAIN PLASTIC COMPONENTS MADE FROM POLYCARBONATE OR ACRYLIC, AND INCLUDE THE ENTIRE HEATER ASSEMBLY, BASSINET SIDE PANELS, COLUMN CAP AND FRONT PANEL FASCIAS. 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 HEAD KIT, REFLECTOR, HEATING ELEMENT AND HEAD HARNESS KIT WERE REPLACED ON THE COMPLAINT INFANT WARMER AND IT WAS RETURNED TO THE CUSTOMER AFTER PASSING THE SAFETY AND PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW934 COSYCOT INFANT WARMER HAD A CRACKED WARMER HEAD CASE. SERVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW934 COSYCOT INFANT WARMER HAD A CRACKED WARMER HEAD CASE. SERVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383279 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 051029

    Patients

    Seq Age Sex Outcome Treatment
    1