BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOTHERAPY SYSTEM 785

    MDR report key: 132821 · Received November 9, 1997

    Report

    Report Number
    MW1012463
    Event Type
    Malfunction
    Date Received
    November 9, 1997
    Date of Event
    November 2, 1997
    Report Date
    November 6, 1997
    Manufacturer
    AIR SHIELDS-VICKERS INC.
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE IN NEONATAL ICU HEARD A POPPING SOUND AND FOUND BROKEN GLASS INSIDE BILILITE AND HOLES IN THE PLASTIC LENS THAT COVERS THE GLASS SHIELDS OVER THE LAMPS. NURSE TURNED THE BILILITE OFF. INSPECTED BY AIR SHIELDS ON SITE 11-4-97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOTHERAPY SYSTEM 785 BILILIGHT (BILILITE) LBI AIR SHIELDS-VICKERS INC. PTM 78-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA EXZ HALOGEN LAMPS USED IN BILILITE MAY BE TOO HOT?