BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY LIGHT

    MDR report key: 1616752 · Received February 24, 2010

    Report

    Report Number
    1836145-2010-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    HILL-ROM ARCHITECTURAL PRODUCTS, HILL ROM CO. INC.
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND ACCORDING TO THE HOUSEKEEPER, THE LIGHT STARTED ARCHING & SPARKING CAUSING A SMALL FIRE. THE ACCOUNTS ENGINEER FOUND THE PLASTIC WIRE HARNESS SHIELDING SPLIT AND EXPOSED THE WIRES. THE ACCOUNT REPAIRED THE LIGHT AND PLACED IT BACK INTO SERVICE. ON 03/17/1988, HILL-ROM SENT A MAILING TO ADVISE ACCOUNTS OF THIS POTENTIAL AND CREATED A SERVICE KIT TO UPGRADE THE LIGHT. HILL-ROM IDENTIFIED THE WIRING WAS BETWEEN THE CENTER HOUSING OF THE LIGHT AND THE FLIP OVER LIGHT. THE REPEATED OPENING AND CLOSING OF THE LIGHT WOULD CAUSE THE WIRE TO FATIGUE IN ONE PLACE AND BREAK. HILL-ROM INCREASED THE NUMBER OF STRANDS IN THE WIRE FROM 17 TO 41 AND REPLACED THE NYLON TUBING THE WIRING WAS CONTAINED IN TO A MORE FLEXIBLE MESH. SINCE HILL-ROM MADE THIS CHANGE, THERE HAVE BEEN NO REPORTED PROBLEMS WITH THE NEWER STYLE. THE 640 MODEL LIGHT WAS LAST PRODUCED IN 08/1984.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE LIGHT CAUGHT FIRE AT THE BENT JOINT AREA OF THE LIGHT. THE UNIT STILL HAD THE HARD PLASTIC SLEEVES HOUSING THE LAMP HOLDER WIRES. HE DOES NOT THINK THE LIGHT WAS EVER MODIFIED WITH REPAIR KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY LIGHT AC POWERED MEDICAL EXAM LIGHT KZF HILL-ROM ARCHITECTURAL PRODUCTS, HILL ROM CO. INC. 645

    Patients

    Seq Age Sex Outcome Treatment
    1