BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE STANDING INFANT WARMER

    MDR report key: 45654 · Received October 23, 1996

    Report

    Report Number
    2510954-1996-00001
    Event Type
    Malfunction
    Date Received
    October 23, 1996
    Report Date
    September 26, 1996
    Manufacturer
    AIR-SHIELDS
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INFANT RADIANT WARMER IN SERVO (SKIN TEMPERATURE) CONTROL CONTINUED TO HEATER A HIGH SET TEMPERATURE ALARM ACTIVATED. A WARMER DISPLAY TEMPERTURE OF 44 DEGREES CENTIGRADE WAS OBSERVED. IT HAS BEEN INDICATED THAT THE INFANT HAS BEEN RELEASED FROM THE HOSP, WITHOUT THE NEED FOR MEDICAL INTERVENTION, OR SUSTAINING A SERIOUS INJURY RELATING TO THIS EVENT REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening