BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 4249356 · Received November 14, 2014

    Report

    Report Number
    9611451-2014-00867
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 16, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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. RESULTS: VISUAL INSPECTION REVEALED A CRACK ON THE RETURNED HEAD WARMER ASSEMBLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070712. 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 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 HEAD CASE AND HARNESS KIT WERE REPLACED ON THE COMPLAINT HEAD WARMER ASSEMBLY AND IT WAS RETURNED TO THE CUSTOMER AFTER PASSING THE SAFETY AND PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT THE HEATER HEAD CASE OF AN IW934 COSYCOT INFANT WARMER WAS CRACKED. A SERVICE OF THE DEVICE WAS REQUESTED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736487 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 070712

    Patients

    Seq Age Sex Outcome Treatment
    1