BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1182684 · Received September 25, 2008

    Report

    Report Number
    9611451-2008-00558
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    June 26, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K970432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL BE CONDUCTED, ONCE WE RECEIVE THE COMPLAINT DEVICE. A FOLLOW UP REPORT WIL BE PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY REPORTED THAT THEY WERE NOT ABLE TO SET THE POWER LEVEL OF MOBILE INFANT WARMER. THE HOSPITAL TECHNICIAN DETERMINED THAT THE CONTROL PCB WAS FAULTY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW910AFU

    Patients

    Seq Age Sex Outcome Treatment
    1