BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR SHIELD

    MDR report key: 442868 · Received February 5, 2003

    Report

    Report Number
    442868
    Event Type
    Other
    Date Received
    February 5, 2003
    Date of Event
    April 1, 2002
    Report Date
    December 16, 2002
    Manufacturer
    HILL ROM/AIR SHIELD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEMPERATURE CONTROL FAILED ON THE SOLID-STATE RELAY HEATING ELEMENTS. THE DEVICE WOULD OVERHEAT, OR NOT HEAT, OR HEAT CONSTANTLY WITH NO ALARMS IN ANY OF THESE SITUATIONS. THE DEVICE SHOULD TURN ON OR OFF DEPENDING ON THE PT'S TEMPERATURE DETECTED BY A PROBE. IF THE SENSOR DIDN'T DETECT CERTAIN TEMPERATURES, THE PT WOULD POTENTIALLY BE COMPROMISED BY DECREASED OR INCREASED TEMPERATURES. THE FACILITY WAS TOLD BY THE MFR THAT THE SERVICE MANUAL INSTRUCTED THEM TO REPLACE THE SOLID-STATE RELAY ON A ROUTINE BASIS BUT THIS REQUIREMENT WAS NOT FOUND BY THE FACILITY IN THE BOOKLET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELD OPEN BED INFANT WARMER FMT HILL ROM/AIR SHIELD RW82-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other