BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1567498 · Received December 23, 2009

    Report

    Report Number
    9611451-2009-00731
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    December 15, 2009
    Report Date
    December 16, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED IN 1995. FISHER & PAYKEL HEALTHCARE HAS REQUESTED PERTINENT INFORMATION TO ASSIST IN OUR ROOT CAUSE ANALYSIS. WE WILL SUBMIT OUR FINDINGS IN A FOLLOW-UP REPORT FOLLOWING RECEIPT OF THE DETAILS REQUESTED AND COMPLETION OF OUR EVALUATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO FISHER & PAYKEL HEALTHCARE'S BRANCH OFFICE IN (B)(4) THAT THE PLASTIC ON THE HEATER HEAD OF AN IW930AEK COSYCOT INFANT WARMER HAD CRACKED AND THE PIECES HAD FALLEN OFF. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW930AEK

    Patients

    Seq Age Sex Outcome Treatment
    1