BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 2996166 · Received March 10, 2013

    Report

    Report Number
    9611451-2013-00171
    Event Type
    Malfunction
    Date Received
    March 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS BASED ON OUR KNOWLEDGE OF THE PRODUCT, INFORMATION AND PHOTOGRAPH PROVIDED BY THE HOSPITAL. RESULTS: THE PHOTOGRAPH REVEALED A LONGITUDINAL CRACK ON THE PLASTIC BASE LEG, UNDER THE COLUMN FOOTING. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 070205. CONCLUSION: BASED ON THE PHOTOGRAPH, THE CRACK DAMAGE TO THE LEG BASE REGION OF THE COSYCOT INFANT WARMER IS KNOWN TO OCCUR WHEN THE UNIT HAS BEEN OVERLOADED. THE MAXIMUM WEIGHT LIMIT IS SPECIFIED IN BOTH THE TECHNICAL MANUAL AND THE OPERATING MANUAL OF THE INFANT WARMER. AN ALUMINIUM METAL BASE HAS BEEN SENT TO THE HOSPITAL FOR REPLACEMENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE ELEVATOR BASE LEG OF AN IW934 COSYCOT INFANT WARMER WAS CRACKED. NO FURTHER INFORMATION SURROUNDING THE FAILURE WAS PROVIDED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100913 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 070205000164

    Patients

    Seq Age Sex Outcome Treatment
    1