BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1946728 · Received January 4, 2011

    Report

    Report Number
    9611451-2010-00811
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Report Date
    December 6, 2010
    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). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. ATTEMPTS TO OBTAIN THE COMPLAINT COMPONENTS, PHOTOGRAPHS AND FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION PROVIDED BY THE BIOMED OF THE MEDICAL CENTER, RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT SERIAL NUMBER PROVIDED (B)(4) BY THE CUSTOMER CORRELATES TO THE NEOPUFF INFANT RESUSCITATOR THAT IS FITTED WITH THE COSYCOT INFANT WARMER. FURTHER SEARCH THROUGH OUR RECORDS IDENTIFIED THE SERIAL NUMBER FOR THE COMPLAINT COSYCOT INFANT WARMER TO BE (B)(4), LOT 020403, DEVICE MANUFACTURER DATE 04/03/2002. A LOT CHECK FOR 020403 REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. THE HOSPITAL REPORTED THAT THE FIRST CRACK IS WHERE THE CASTOR IS MOUNTED AND THE SECOND CRACK IS ON THE TOP, WHERE IT IS MOST LIKELY ON THE AREA WHERE THE COT COLUMN RESTS. CRACKS TO THE LEG BASE REGION OF THE COSYCOT INFANT WARMER ARE KNOWN TO OCCUR WHEN IT HAS BEEN OVERLOADED. THE BIOMED REPORTED THAT THE COSYCOT UNIT HAD A PLASTIC BASE AND AN ADDITIONAL NON-FPH ACCESSORY, A MONITOR, WAS ADDED TO COSYCOT INFANT WARMER. IT IS LIKELY THAT WITH THIS ADDITIONAL MONITOR, THE MAXIMUM WEIGHT CAPACITY OF THE COSYCOT INFANT WARMER WAS EXCEEDED. TOTAL WEIGHT OF THE DEVICE, INCLUDING ACCESSORIES AND PATIENT, EXCEEDING 115 KG MAY, UNDER CERTAIN CIRCUMSTANCES, CAUSE CRACKS IN THE PLASTIC LEGS' BASE AND DAMAGE TO THE BASE ELECTRIC ELEVATOR MECHANISM. 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. AN ALUMINIUM METAL BASE, WITH A MAXIMUM CAPACITY OF 140KG HAS BEEN SENT FOR REPLACEMENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE LEGS OF AN IW934 COSYCOT INFANT WARMER WERE CRACKED. THE HOSPITAL FURTHER REPORTED THAT "ONE PLASTIC LEG IS CRACKED WHERE THE WHEEL ATTACHES TO IT AND ANOTHER LEG IS CRACKED ALONG THE TOP". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE LEGS OF AN IW934 COSYCOT INFANT WARMER WERE CRACKED. THE HOSPITAL FURTHER REPORTED THAT "ONE PLASTIC LEG IS CRACKED WHERE THE WHEEL ATTACHES TO IT AND ANOTHER LEG IS CRACKED ALONG THE TOP". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934JEU 020404

    Patients

    Seq Age Sex Outcome Treatment
    1