BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOTHERAPY SYSTEM 7850

    MDR report key: 198624 · Received November 18, 1998

    Report

    Report Number
    2510954-1998-00007
    Event Type
    Malfunction
    Date Received
    November 18, 1998
    Date of Event
    October 16, 1998
    Report Date
    October 16, 1998
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPLACED THE PHOTO THERAPY LAMPS WITH INCORRECT LAMPS, NOT PROVIED BY HILL-ROM AIR-SHIELDS. THE RESULT WAS SHATTERING OF THE INFRARED (IR) FILTER, WHICH FELL ON TO THE ULTRAVIOLET (UV) FILTER CAUSING IT TO PARTIALLY MELT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOTHERAPY SYSTEM 7850 NEONATAL PHOTOTHERAPY LBI HILL-ROM AIR-SHIELDS PTM78 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN