BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILITX LIGHT SOURCE

    MDR report key: 4846615 · Received June 16, 2015

    Report

    Report Number
    1218950-2015-03171
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Report Date
    June 2, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LBI
    PMA / PMN Number
    K070180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT LINCOLN HEALTH STATING THAT THE FIBER OPTIC PANEL OF A BILITX HAD THERMAL DAMAGE ON THE CONNECTOR. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE HAS BEEN NO ALLEGATION OF HARM REPORTED AND IT HAS NOT BEEN SPECIFIED IF THE THERMAL DAMAGE WAS FROM AN OUTSIDE SOURCE OR NOT. BASED ON A COMPLETE REVIEW OF THE COMPLAINT ALLEGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE REQUIRES FURTHER INVESTIGATION. ONCE THE DEVICE IS RETURNED FOR INVESTIGATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED TO DETAIL THE FINDINGS AND THE NEED FOR ANY POSSIBLE FURTHER ACTION.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT (B)(6) STATING THAT THE FIBER OPTIC PANEL OF A BILITX HAD THERMAL DAMAGE ON THE CONNECTOR. THERE HAS BEEN NO ALLEGATION OF HARM REPORTED AND IT HAS NOT BEEN SPECIFIED IF THE THERMAL DAMAGE WAS FROM AN OUTSIDE SOURCE OR NOT.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT LINCOLN HEALTH STATING THAT THE FIBER OPTIC PANEL OF A BILITX HAD THERMAL DAMAGE ON THE CONNECTOR. THE CUSTOMER STATED THAT THE DEVICE WAS IN USE BUT NO HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391638 BILITX LIGHT SOURCE NEONATAL PHOTOTHERAPY LBI PHILIPS MEDICAL SYSTEMS 1041725

    Patients

    Seq Age Sex Outcome Treatment
    1