BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2072364 · Received April 29, 2011

    Report

    Report Number
    9611451-2011-00273
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE ALLEGED INJURY WERE UNSUCCESSFUL. THE COMPLAINT COSYCOT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. PHOTOGRAPHS OF THE COMPLAINT COSYCOT HAVE BEEN PROVIDED BY THE HOSPITAL. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION, ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. THE PHOTOGRAPHS REVEALED THAT THE COMPLAINT COSYCOT WAS FITTED WITH ADDITIONAL ACCESSORIES WITH AN APPROXIMATE CALCULATION OF 56KG IN TOTAL WEIGHT (WITHOUT PATIENT). THE COSYCOT PLASTIC BASE IS DESIGNED TO CARRY A MAXIMUM LOAD OF 54KG (INCLUDING THE PATIENT) FOR A TOTAL WEIGHT OF 115KG. THE MAXIMUM WEIGHT LIMIT IS SPECIFIED IN BOTH THE TECHNICAL MANUAL AND THE OPERATING MANUAL OF THE INFANT WARMER. TO INCREASE AWARENESS AND TO PREVENT AND/OR REDUCE THE INCIDENCE OF CRACKED BASES, A WARNING IS PROVIDED IN THE FORM OF A "115KG MAX WEIGHT" LABEL APPLIED TO THE COLUMN OF THE INFANT WARMER. THE HOSPITAL FURTHER REPORTED THAT THE COMPLAINT COSYCOT IS TRANSPORTED UP TO 100 METERS, CROSSING BOTH LINOLEUM AND CARPETED FLOORING AND "SOMETIMES USED VIA INTERNAL LIFTS SO GOES OVER THE GAP BETWEEN THE FLOOR AND THE LIFT". THEY HAVE ALSO REPORTED THAT THE CASTOR IS MISALIGNED AND THAT THE UNIT VEERS TO THE LEFT. THE PHOTOGRAPH PROVIDED BY THE HOSPITAL REVEAL THE CIRCLIP SECURITY PLATE OF THE LEFT CASTOR TO BE OUT OF POSITION, INDICATING THAT THE THREADED CASTOR CONNECTION TO THE BASE IS SLIGHTLY LOOSE. IT IS POSSIBLE THAT THE BASE LEGS ENCOUNTERED ACCIDENTAL IMPACT THROUGH COLLISION WITH WALLS OR SWINGING DOORS. THIS DAMAGE IS LIKELY TO HAVE AFFECTED THE CASTOR AS WELL AND WOULD HAVE BEEN EXAGGERATED IF THE UNIT HAD BEEN WHEELED OVER UNEVEN FLOORS DURING ITS EIGHT YEARS OF USAGE. A MISALIGNED CASTOR WILL BE EVIDENT TO THE USER AS THIS WILL RESULT IN STEERING PERFORMANCE ISSUES. THE PRODUCT TECHNICAL MANUAL ADVISES THAT THE CASTORS SHOULD BE CHECKED TO ENSURE THAT THEY ROLL AND LOCK PROPERLY AS PART OF THE ANNUAL FUNCTIONAL CHECK.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW950 COSYCOT INFANT WARMER WAS "NOT DRIVING STRAIGHT". THE HOSPITAL ALSO REPORTED IN PASSING THAT A STAFF MEMBER WAS INJURED AND THAT THIS MAY HAVE BEEN RELATED TO THEIR USE OF THE COSYCOT INFANT WARMER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW950 COSYCOT INFANT WARMER WAS "NOT DRIVING STRAIGHT." THE HOSPITAL ALSO REPORTED IN PASSING THAT A STAFF MEMBER WAS INJURED AND THAT THIS MAY HAVE BEEN RELATED TO THEIR USE OF THE COSYCOT INFANT WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW950AEA 030606

    Patients

    Seq Age Sex Outcome Treatment
    1