BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE 2820 LIGHT; OR ALPHA SOURCE BULB

    MDR report key: 257056 · Received January 3, 2000

    Report

    Report Number
    3019090-2000-00001
    Event Type
    Other
    Date Received
    January 3, 2000
    Date of Event
    December 3, 1999
    Report Date
    December 3, 1999
    Manufacturer
    GETINGE/CASTLE, INC.
    Product Code
    FQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A BULB BURST IN THE SURGICAL LIGHT DURING A PROCEDURE. THE BULBS IN USE WERE NOT SUPPLIED BY THE LIGHT'S MFR, GETINGE/CASTLE. FRAGMENTS EXITED THE LIGHTHEAD AND POSSIBLY ENTERED THE PT. PER THE HOSPITAL, NO IMMEDIATE ILL-EFFECTS ON THE PT WERE OBSERVED. THERE WILL BE ONGOING MONITORING. THE LIGHT WAS INSTALLED IN 1990. THIS MODEL IS NO LONGER IN PRODUCTION. CO'S FIELD TECHNICIAN DID NOT OBSERVE ANY ELECTRICAL PROBLEMS THAT HE FELT WOULD CAUSE A BULB TO BURST. THERE IS NO DATA TO SUPPORT THAT THERE IS A TREND OF BULBS BURSTING IN THIS MODEL LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE 2820 LIGHT; OR ALPHA SOURCE BULB SURGICAL LIGHT; OR LIGHT BULB FQP GETINGE/CASTLE, INC. 2820 (SURGICAL LIGHT) *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other ALPHA SOURCE LIGHT BULBS.