BEUDAMED
    FDA Adverse Event Other Summary report: N

    RW RESUSCITAIRE

    MDR report key: 336325 · Received June 4, 2001

    Report

    Report Number
    2510954-2001-00008
    Event Type
    Other
    Date Received
    June 4, 2001
    Date of Event
    March 10, 2001
    Report Date
    June 2, 2001
    Manufacturer
    HILL-ROM MANUFACTURING INC
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM AIR-SHIELDS RECEIVED MEDWATCH FORM AND EMAIL FROM CUSTOMER STATING CONCERNS. CUSTOMER STATED THAT CUSTOMER HAS A CONCERN REGARDING THE USE OF OZYGEN AND NOT MEDICAL GRADE AIR FOR THE GENERATION OF SUCTION ON THE CO'S RW RESUSCITAIRE INFANT RADIANT WARMER. NO ADVERSE EVENT WAS REPORTED, ONLY THE CUSTOMER'S CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25755 RW RESUSCITAIRE INFANT RADIANT WARMER FMT HILL-ROM MANUFACTURING INC RESUSCITAIRE *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other