BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOTHERAPY LIGHT

    MDR report key: 223855 · Received May 12, 1999

    Report

    Report Number
    2018492-1999-00004
    Event Type
    Malfunction
    Date Received
    May 12, 1999
    Date of Event
    April 5, 1999
    Report Date
    May 10, 1999
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Product Code
    LBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING ROUTINE CLEANING OF THE LAMP, THE PIVOT SUPPORT FRACTURED CAUSING THE LIGHT TO FALL INTO THE EMPTY INFANT WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOTHERAPY LIGHT MEDICAL LIGHT LBI BURTON MEDICAL PRODUCTS CORP. 6600-0527-200 BURT 391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other