BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL SPOT

    MDR report key: 355377 · Received October 9, 2001

    Report

    Report Number
    MW1023048
    Event Type
    Malfunction
    Date Received
    October 9, 2001
    Report Date
    October 9, 2001
    Manufacturer
    BURTON MEDICAL PRODUCTS
    Product Code
    FCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TWO OCCASIONS WHERE BURTON EXAM LIGHT ARM/LIGHT HEAD ASSEMBLIES SEPARATED FROM THE DOWN TUBE AND FELL. THE FIRST FELL AND STRUCK AN INCUBATOR WITH A PT ON BOARD IN THE NICU. THE SECOND, ALSO IN THE NICU, BROKE WHILE BEING POSITIONED BY A STAFF MEMBER. THE LIGHT WAS CAUGHT BY THE STAFF MEMBER, BUT WAS LEFT HANGING BY THE ELECTRICAL WIRING UNTIL ENGINEERING ARRIVED TO REMOVE THE DEVICE. NO PT HARM OCCURRED IN EITHER EVENT. BURTON HAS REPLACED ALL ARM ASSEMBLIES AT NO CHARGE TO THE HOSP, BUT HOSP FEEL IT PRUDENT TO REPORT THESE EVENTS BECAUSE OF CONCERN FOR SAFETY AND QUALITY MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45379 COOL SPOT LIGHTS, EXAMINATION FCQ BURTON MEDICAL PRODUCTS 0134522 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *