BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOTHERAPY LIGHT

    MDR report key: 107304 · Received July 17, 1997

    Report

    Report Number
    2018492-1997-00005
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Date of Event
    June 10, 1997
    Report Date
    July 17, 1997
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WALL MOUNT PT1400'S PIVOT ASSEMBLY RESULTING IN THE LAMP ASSEMBLY BEING SUPPORTED BY THE INTERNAL WIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOTHERAPY LIGHT PHOTOTHERAPY LIGHT FSY BURTON MEDICAL PRODUCTS CORP. 1009005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN