BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILITX LIGHT SOURCE

    MDR report key: 4814676 · Received June 3, 2015

    Report

    Report Number
    1218950-2015-02942
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    May 10, 2015
    Report Date
    May 12, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LBI
    PMA / PMN Number
    K070180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WAS A SMALL RED MARK ON THE PATIENT AND NO MEDICAL CARE WAS REQUIRED. THE DEVICE WAS IN USE AT THE TIME OF THE ALLEGED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED INCIDENT AND TO OBTAIN THE PRODUCT BACK FOR EVALUATION. TWO PEOPLE WERE CONTACTED AT THE CUSTOMER SITE. ONE DID NOT HAVE ANY ADDITIONAL INFORMATION AND ONE DID NOT RETURN OUR CALLS. BECAUSE THE PRODUCT WAS NOT ABLE TO BE EVALUATED, THE REPORTED PROBLEM CANNOT BE CONFIRMED. THE PRODUCT REMAINS AT THE CUSTOMER SITE. THERE HAVE BEEN NO ADDITIONAL CALLS FROM THE CUSTOMER, SUGGESTING THE REPORTED PROBLEM HAS NOT RECURRED. THE INVESTIGATION DID NOT DETERMINE WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT OUTCOME BECAUSE THE CUSTOMER DID NOT RESPOND TO MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION. THEREFORE, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF INSUFFICIENT INFORMATION/UNKNOWN CAUSE FOR REPORTING PURPOSES ONLY.

    Additional Manufacturer Narrative · 1

    BASED ON A COMPLETE REVIEW OF THE COMPLAINT ALLEGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE IS REPORTABLE DUE TO THE POSSIBILITY OF PATIENT HARM. 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 FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT A BILITX DEVICE POSSIBLY BURNED A PATIENT. THE DME STATED THAT THERE WAS A SMALL RED MARK ON THE PATIENT. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. THEREFORE, DUE TO THE LACK OF ADDITIONAL INFORMATION REGARDING TREATMENT OF THE PATIENT, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY AT THIS TIME.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT FROM A DURABLE (B)(4) SUPPLIER STATING THAT A BILITX DEVICE POSSIBLY BURNED A PATIENT. THE DME STATED THAT THERE WAS A SMALL RED MARK ON THE PATIENT AND NO MEDICAL CARE WAS REQUIRED. THE DEVICE WAS IN USE AT THE TIME OF THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360170 BILITX LIGHT SOURCE NEONATAL PHOTOTHERAPY LBI PHILIPS MEDICAL SYSTEMS 1041725

    Patients

    Seq Age Sex Outcome Treatment
    1