BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFANT INTENSIVE CARE SYSTEM

    MDR report key: 98258 · Received June 13, 1997

    Report

    Report Number
    2510954-1997-00004
    Event Type
    Death
    Date Received
    June 13, 1997
    Date of Event
    May 17, 1997
    Report Date
    June 5, 1997
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A HOSPITAL BIOMEDICAL ENGINEER, THE INFANT INVOLVED WAS VERY SICK AND THE STAFF HAD BEEN STRUGGLING TO KEEP THE INFANT ALIVE FOR APPROX 5 DAYS SINCE BIRTH. IT HAS BEEN INDICATED THAT DURING A PROCEDURE A PHYSICIAN REMOVED THE SKIN TEMPERATURE PROBE FROM THE INFANT, AFFIXED THE PROBE TO THE WARMER POST AND FORGOT TO RE-SECURE IT TO THE INFANT AFTER THE PROCEDURE. THE TEMPERATURE PROBE IS USED TO SERVO CONTROL THE RADIANT WARMER HEATER IN ORDER TO KEEP THE INFANT SKIN TEMPERATURE AT THE SELECTED VALUE. THE INFANT'S SKIN TEMPERATURE WAS INDICATED TO HAVE REACHED 104 DEGREES FAHRENHEIT (40 DEGREES CELSIUS). IT WAS ALLEGED BY A NURSE THAT NO ALARM OCCURRED DURING THE EVENT. HOWEVER, THE HOSPITAL'S BIOMEDICAL ENGINEER HAS INDICATED THAT THE HOSPITAL DOES NOT CONSIDER WARMER PERFORMANCE TO BE THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTENSIVE CARE SYSTEM INFANT RADIANT WARMER FMT AIR SHIELDS, INC. 7880 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death