BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE DELUXE MODEL 50 CHROME EXAM LAMP

    MDR report key: 1584294 · Received January 7, 2010

    Report

    Report Number
    1584294
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    GOODWIN MANUFACTURING, INC.
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY BOUGHT A NEW GOOSENECK MEDI CHOICE EXAM LAMP FROM OWENS & MINOR. THE LABELING ON THE BOX INDICATES O & M GOT IT FROM GOODWIN MANUFACTURING. IT'S AN IMPORT & FOREIGN-MADE. LEAKAGE TESTS ON INCOMING SEEMED PECULIAR. THE HG (HOSPITAL GRADE) PLUG WAS OPENED AND THEY FOUND THE INSULATION CUT TO THE COPPER OF ALL THREE CONDUCTORS WHERE THE OUTER SHEATH WAS REMOVED. THE BLACK WIRE HAD ONLY THE BITTER END OF A SINGLE STRAND CLAMPED AND THE POLARITY WAS REVERSED. GOODWIN WAS CALLED AND ADVISED ABOUT THE PROBLEM BY THE FACILITY. THE FACILITY ADVISED OTHER STAFF TO BE ON WATCH FOR ANY BOX SAYING "DELUXE MODEL 50 CHROME EXAM LAMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE DELUXE MODEL 50 CHROME EXAM LAMP GOOSENECK EXAM LAMP KZF GOODWIN MANUFACTURING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *