BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE STANDING INFANT WARMER

    MDR report key: 167124 · Received May 7, 1998

    Report

    Report Number
    2510954-1998-00004
    Event Type
    Malfunction
    Date Received
    May 7, 1998
    Date of Event
    April 7, 1998
    Report Date
    April 7, 1998
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    A HILL-ROM AIR-SHIELDS SERVICE ENGINEER NOTICED A BROKEN WELD ON THE LOWER POST OF THE RADIANT WARMER. THE WELDING FAULT WAS DETECTED DURING SETUP. THE BROKEN WELD WAS LOCATED AT THE BOTTOM OF THE POST, WHERE THE POST MOUNTS TO THE BASE, IN ORDER TO SUPPORT THE WARMER MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE STANDING INFANT WARMER INFANT RADIANT WARMER FMT HILL-ROM AIR-SHIELDS 7830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA