BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1851073 · Received September 28, 2010

    Report

    Report Number
    9611451-2010-00587
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Report Date
    September 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HEATER HEAD ASSEMBLY OF AN IW910JEU MOBILE INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO FISHER & PAYKEL HEALTHCARE'S (FPH) CUSTOMER CARE SPECIALIST IN OUR (B)(4) OFFICE THAT THE WARMER HEAD OF AN IW910JEU MOBILE INFANT WARMER WAS CRACKED AT THE HINGE DOOR. THIS WAS NOTICED DURING USE ON A PT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1