BEUDAMED
    FDA Adverse Event Other Summary report: N

    7880 INFANT WARMER

    MDR report key: 250794 · Received November 22, 1999

    Report

    Report Number
    MW1017596
    Event Type
    Other
    Date Received
    November 22, 1999
    Date of Event
    September 28, 1999
    Report Date
    October 14, 1999
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EQUIPMENT IN QUESTION WAS BEING UTILIZED BY THE NEONATAL INTENSIVE CRITICAL CARE UNIT DEPARTMENT ON 9/28/99. STAFF MEMBERS STATED THAT THE UNIT HAD BEEN ENERGIZED FOR APPROX 10 MINS WHEN THEY SMELLED SOMETHING BURNING. A CLOSER VIEW OF THE UNIT NOTED THAT THE PROTECTIVE PLASTIC THAT IS SITUATED OVER THE PHOTOMETER BULBS HAD MELTED, AND A PIECE OF GLASS THAT IS LOCATED BETWEEN THE PLASTIC AND THE BULBS HAD FALLEN THROUGH THE PLASTIC AND ONTO THE INFANT, BURNING THE INFANT'S BACK. THE BIOMEDICAL ENGINEERING DIVISION RETRIEVED THE UNIT FOR ASSESSMENT AND LEGALITY PURPOSES. THE FOLLOWING DISCREPANCIES WERE NOTED: THE PLASTIC COVER WAS MELTED IN TWO PLACES, AND 2 OF THE GLASS COVERS LOCATED BETWEEN THE BULBS AND PLASTIC WERE SHATTERED. AS PER MFR SPECIFICATIONS THE BULBS WERE CORRECT, 50W, 12V, AND THE COOLING FAN CAME ON UPON ENERGIZING THE UNIT. CONCLUSIONS: AS PER THE OPERATOR IT WAS KNOWN THAT THE UNIT HAD BEEN USED THE ENTIRE DAY ON 9/27/99; SO IT IS REPORTER'S OPINION THAT THE GLASS HAD TO HAVE BEEN BROKEN BETWEEN THE NIGHT OF 9/27/99 AND THE MORNING OF 9/28/99. DUE TO THE BULKINESS OF THE UNIT, IT MAY HAVE BEEN BUMPED INTO A VARIETY OF OBSTACLES ACCIDENTLY, THUS SHATTERING THE PROTECTIVE GLASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7880 INFANT WARMER INFANT RADIANT WARMER FMT HILL-ROM AIR-SHIELDS CBA781 MODULE ASSY *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other