BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1633381 · Received March 12, 2010

    Report

    Report Number
    9611451-2010-00137
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 11, 2010
    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). METHOD: THE BIOMEDICAL ENGINEER AT THE HOSP EVALUATED THE COMPLAINT WARMER AND PROVIDED INFO AND PHOTOGRAPHS OF THE DAMAGED WARMER FOOT COMPONENT. RESULTS: THE BIOMEDICAL ENGINEER AT THE HOSP REPORTED THAT THE BUSH ON THE WHEEL ASSEMBLY WAS DAMAGED. A PHOTOGRAPH OF THE FOOT BASE AXLE AND BUSH CONFIRMED THE REPORTED DAMAGE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 071008. CONCLUSION: THE ROOT CAUSE OF THE STEERING PROBLEM IS A DAMAGED BUSH. BASED ON THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER, IT APPEARS THAT THE BUSH WAS DAMAGED DURING THE ASSEMBLY OF TWO OF THE FOOT COMPONENTS WHEN THE HOSPITAL UPGRADED TO THE PLASTIC BASE TO A METAL BASE AND THAT THE DAMAGE BECAME APPARENT AFTER USE OF THE WARMER. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE HAVE RECEIVED FOR A METAL COSYCOT INFANT WARMER BASE.

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED THAT AN IW932 COSYCOT INFANT WARMER WAS DIFFICULT TO STEER. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW932AEA 071008

    Patients

    Seq Age Sex Outcome Treatment
    1