BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALITE

    MDR report key: 1691259 · Received May 12, 2010

    Report

    Report Number
    1824206-2010-07150
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 13, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN REMOVED THE LEFT END CAP AND FOUND THAT THE CLEAR INSULATION AND WIRING HARNESS POWERING THE UPPER LIGHT WAS BURNT IN HALF. CUSTOMER DESCRIPTION: ON SUNDAY, (B) (6) 2010, AT ABOUT 11:30AM, THE LIGHT ABOVE THE BED IN PATIENT ROOM (B) (6), WAS OBSERVED SMOKING. THE NURSE IMMEDIATELY TURNED OFF THE LIGHT BY USING THE PULLCHAIN. THE PATIENT IN THE ROOM WAS MOVED TO ANOTHER ROOM. NO INJURIES. ON MONDAY, (B) (6) 2010, MAINTENANCE WAS NOTIFIED AND POWER TO THE LIGHT WAS SHUT OFF. ROOM IS VACANT AT THIS TIME. ADVISED MAINTENANCE TO INSPECT ALL WIRING HARNESSES. THE CUSTOMER SERVICE BULLETIN DATED (B) (6) 1988 WAS PROVIDED TO THE CUSTOMER. ACCOUNT STATED THAT HE HAS REPLACED THE WIRING HARNESS IN QUESTION AND THE LIGHT IS FUNCTIONING PROPERLY. NO FURTHER ISSUES. ACCOUNT IS REPLACING ALL OTHER HARNESSES AT THE FACILITY AS A PRECAUTION AS ROOMS BECOME AVAILABLE.

    Description of Event or Problem · 1

    ACCOUNT STATED THAT THE WIRES WHERE P640 LIGHT FLIPS OVER SMOKED AND BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALITE EXAM LIGHT KZF HILL-ROM INC. P645-00000618

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK