BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR-SHIELDS BABY WARMER

    MDR report key: 10395 · Received November 16, 1993

    Report

    Report Number
    10395
    Event Type
    Other
    Date Received
    November 16, 1993
    Date of Event
    October 14, 1993
    Report Date
    November 3, 1993
    Manufacturer
    AIR-SHIELDS VICKERS
    Product Code
    FMT
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 10/14/93 AT APPROXIMATELY 1:30 PM NURSE CALLED AND SAID THAT TEMP PROBE ON BABY ON AN INFANT WARMER IN NEWBORN NURSERY HAD EXPLODED AND BURNED THE BABY. BIOMEDICAL SUPERVISOR AND BIOMEDICAL TECH ALONG WITH AN ELECTRONIC STUDENT WENT TO NURSERY IMMEDIATELY. TEMP PROBE ELECTRICAL CORD WAS CAUGHT IN FUSE HOLDER AT THE BACK OF THE POWER MODULE FOR THE INFANT WARMER, SERIAL #GZ06827, STATE TAG #390-10-14791. THE NURSE THEN REMOVED THE PROBE. THE INFANT HAD PREVIOUSLY BEEN REMOVED FROM THE WARMER AND WAS BEING CARE FOR BY OTHER NURSES. UPON EXAMINING THE PROBE THE INSULATION WAS MELTED AWAY WHERE IT HAD BEEN CAUGHT IN THE FUSE HOLDER. THERREFORE A PORTION OF THE CURRENT WAS OBVIOUSLY DIRECTED THROUGH THE SMALL DIAMETER WIRING OF THE TEMP PROBE. THIS SMALL WIRE CARRYING SUCH A LARGE AMOUNT OF CURRENT ALLOWS FOR A GREAT AMOUNT OF HEAT TO DEVELOP. A 3 MM BLISTERED AREA NOTED ON LEFT SIDE OF BABY. NO PERMANENT MARKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR-SHIELDS BABY WARMER POWER MODULE FOR BABY WARMER FMT AIR-SHIELDS VICKERS

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other