BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTURION

    MDR report key: 69693 · Received February 12, 1997

    Report

    Report Number
    2027060-1997-09001
    Event Type
    Other
    Date Received
    February 12, 1997
    Date of Event
    December 20, 1996
    Report Date
    February 12, 1997
    Manufacturer
    MEDICAL ILLUMINATION
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CEILING MOUNTED LIGHT FELL FROM THE CEILING AFTER BEING ARTICULATED. NO PT WAS INVOLVED. THE LIGHT WAS SHIPPED TO THE MFR FOR EVALUATION. A TECH WAS SENT IN TO INSPECT THE HOSP'S REMAINING THIRTEEN (13) CEILING MOUNTED LIGHTS. IT WAS NOTED THAT THE HOSP-INSTALLED CEILING RODS HAD BEEN CUT OFF AT THE BOTTOM INSTEAD OF THE TOP. MFR HAD IMPROVED THE DESIGN SINCE THESE PARTICULAR LIGHTS WERE MFG. NEWLY DESIGNED CEILING RODS AND BUSHING ASSEMBLIES WERE SHIPPED TO THE HOSP. PER MFR THE RETURNED UNIT WAS REPAIRED USING THE UPGRADED PARTS. THIRTEEN (13) ADD'L UPGRADED KITS WERE SENT TO FACILITY FOR RETROFITTING THEIR EXISTING LIGHTS WITH AN ESTIMATED COMPLETION DATE OF 2/18/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION SURGICAL LIGHTING FQP MEDICAL ILLUMINATION 021514 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other