BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILITX LIGHT SOURCE

    MDR report key: 5896730 · Received August 23, 2016

    Report

    Report Number
    1218950-2016-05191
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Report Date
    July 8, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LBI
    PMA / PMN Number
    K070180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS REPLACING EMDR # 1051786-2016-00010. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT STATING THAT ON (B)(6) 2016 A BILITX DEVICE LEFT A BURN ON THE PATIENT'S BACK. THE DOCTOR WAS TREATING THE PATIENT AS HAVING A BAD SUNBURN, USING TOPICAL CREAM. APPLICATION OF A TOPICAL CREAM IS NOT CONSIDERED TO BE TREATMENT TO PREVENT PERMANENT IMPAIRMENT AND IT WAS NOT REPORTED THAT THE PATIENT REQUIRED ANY OTHER TREATMENT THAT WOULD HAVE PREVENTED PERMANENT IMPAIRMENT. THEREFORE, WE ARE NOT CONSIDERING THIS TO BE A SERIOUS INJURY.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT STATING THAT ON (B)(6) 2016, A BILITX DEVICE LEFT A BURN ON THE PATIENT'S BACK. THE DME STATED THAT A DOCTOR WAS TREATING THE PATIENT AS HAVING A BAD SUNBURN USING TOPICAL CREAM. APPLICATION OF A TOPICAL CREAM IS NOT CONSIDERED TO BE TREATMENT TO PREVENT PERMANENT IMPAIRMENT AND IT WAS NOT REPORTED THAT THE PATIENT REQUIRED ANY OTHER TREATMENT THAT WOULD HAVE PREVENTED PERMANENT IMPAIRMENT. THEREFORE, WE ARE NOT CONSIDERING THIS TO BE A SERIOUS INJURY. THE DEVICE WAS IN USE WHEN THE INCIDENT REPORTEDLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549999 BILITX LIGHT SOURCE NEONATAL PHOTOTHERAPY LBI PHILIPS MEDICAL SYSTEMS 1041725

    Patients

    Seq Age Sex Outcome Treatment
    1 22 DA Other