BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1584644 · Received January 20, 2010

    Report

    Report Number
    9611451-2010-00024
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Report Date
    December 21, 2009
    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). THE HEAD WARMER ASSEMBLY WAS RETURNED TO FISHER & PAYKEL HEALTHCARE, INC. IN (B)(4) FOR EVAL. METHOD: THE RETURNED HEAD WARMER ASSEMBLY WAS VISUALLY INSPECTED FOR DAMAGE AND TESTED. RESULTS: THERE WAS NO VISIBLE DAMGE TO THE EXTERIOR OR INTERIOR OF THE RETURNED WARMER ASSEMBLY. WHEN THE UNIT WAS BEING TESTED, IT IMMEDIATELY DISPLAYED AN ERROR CODE WHICH WAS ISOLATED TO THE HEATER ELEMENT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070301. CONCLUSION: IT WAS REPORTED THAT THE HEATER HEAD WAS "NOT WORKING". WHEN THE HEAD WAS TESTED, THE UNIT DISPLAYED AN ERROR CODE TO ALERT THE USER. THE ROOT CAUSE OF THE FAULTY HEATER HEAD WAS ISOLATED TO THE HEATER ELEMENT, WHICH WAS FOUND TO BE OPEN CIRCUIT. A SEARCH OF OUR DATABASE REVEALED A TOTAL OF 12 COMPLAINTS OF OPEN CIRCUITS IN HEATER HEADS IN THE PAST YEAR TO THE END OF (B)(6) 2009.

    Description of Event or Problem · 1

    THE HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE WARMER HEAD ON AN IW934 COSYCOT INFANT WARMER WAS "NOT WORKING". 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. IW934JEU 070301

    Patients

    Seq Age Sex Outcome Treatment
    1