BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALITE

    MDR report key: 1900652 · Received November 9, 2010

    Report

    Report Number
    1824206-2010-10924
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNTS MAINTENANCE REPLACED THE P645 SPECIALTIES' LAMP HOLDER AND HAS PLACED THE LIGHT BACK INTO SERVICE. HILL-ROM HAS SEEN SIMILAR OVERHEATING CONDITIONS IN 2-PIN, STRAIGHT LAMP FLUORESCENT LIGHTING FIXTURES. THE NATURE OF THIS TYPE OF EVENT SUGGESTS THIS CONDITION COULD OCCUR IN ANY OF THIS TYPE OF FLUORESCENT LIGHTING PRODUCTS, NOT JUST THOSE PROVIDED BY HILL-ROM. POTENTIAL CAUSES ARE: IF A 2-PIN FLUORESCENT LAMP (BULB) IS NOT SECURELY SEATED IN THE LAMP HOLDER, ELECTRICAL ARCING CAN OCCUR BETWEEN THE PINS OF THE FLUORESCENT LAMP AND THE LAMP HOLDER. IF THE ELECTRICAL ARCING IN SUSTAINED FOR AN EXTENDED DURATION, THE LAMP HOLDER MAY OVERHEAT AND POTENTIALLY IGNITE. THE RISK OF SUSTAINED ELECTRICAL ARCING IS GREATER FOR FLUORESCENT LIGHT FIXTURES THAT USE: PARALLEL BALLASTS INSTEAD OF SERIAL BALLASTS. ELECTRICAL BALLASTS INSTEAD OF MAGNETIC BALLASTS. T12 LAMPS INSTEAD OF T8 LAMPS. OUR INVESTIGATION ALSO SUPPORTS THAT A PROPERLY SEATED LAMP IN THE FIXTURE WILL NOT HAVE THIS POTENTIAL HAZARD REGARDLESS OF WHICH LAMP OR BALLAST IS USED. HILL-ROM HAS INFORMED ITS CUSTOMER BASE TO ENSURE PROPER INSTALLATION OF BULBS INTO FIXTURES.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED, THEY HAD AN INCIDENT WITH WIRING BURNING ON THE INSIDE OF THE P645 LIGHT. THE INCIDENT IN RM 3616 HAPPENED OVER THE WEEKEND. NOTHING IS KNOWN AS TO IF THE ROOM WAS OCCUPIED AT THE TIME OF THE EVENT. NO INJURY WAS REPORTED. THE TECH WAS ABLE TO INSPECT THE LIGHT AND HOLDERS. HE FOUND THE HOLDERS WERE SMOKED BROWN IN COLOR AND THERE WAS SOME MELTING AROUND THE CENTER OF THE LAMP HOLDERS AND THE BACKS OF THE HOLDERS WERE OPEN. THE ACCOUNT HAS REPAIRED THE LIGHT AND PLACED IT BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALITE EXAM LIGHT FSY HILL-ROM, INC. 645

    Patients

    Seq Age Sex Outcome Treatment
    1