BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA

    MDR report key: 409039 · Received August 2, 2002

    Report

    Report Number
    MW1025754
    Event Type
    Malfunction
    Date Received
    August 2, 2002
    Report Date
    August 2, 2002
    Manufacturer
    *
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/16/02: THE PRODUCT PHOTOTHERAPY LIGHTS MENTIONED ARE NOT SOLD BY RH BURTON CO. NOT SURE WHAT THIS PRODUCT IS, BUT THERE IS ANOTHER BURTON MEDICAL PRODUCTS CO IN ANOTHER STATE.

    Description of Event or Problem · 1

    WHILE CONDUCTING A RANDOMIZED CLINICAL TRIAL OF AGGRESSIVE VS CONSERVATIVE PHOTOTHERAPY IN PREMATURE INFANTS, A PHYSICIAN WAS ALARMED BY HIGH UVA READINGS THAT WERE OBTAINED FROM THE PHOTOTHERAPY SPOTLIGHTS. THE SPOTLIGHT READINGS ARE ORDERS OF MAGNITUDE HIGHER THAN THE CURRENT IEC NEONATAL PHOTOTHERAPY STANDARD (1X10 TO NEGATIVE 2 MICROWATTS) AND COULD BE HARMFUL TO INFANTS. ABOUT HALF OF THE NEONATAL UNITS IN THE STUDY USE THESE SPOTLIGHTS AS THE MAIN SOURCE OF PHOTOTHERAPY. THESE LIGHTS ARE WIDELY USED ACROSS THE COUNTRY AND INTERNATIONALLY. THE PHYSICIAN REQUESTS THAT THE FDA DETERMINE IF THIS IS A DANGER. SUMMARY OF THE PHYSICIAN'S FINDINGS: SPOTLIGHTS: OHMEDA, DISTANCE: 78CM, UVA METER: 22.5. DISTANCE: 43CM UVA METER 69, IRRADIANCE: 16.7, UVA METER: 34. DISTANCE 72 CM, IRRADIANCE: 9.7, UVA METER: 42, DISTANCE: 55 CM, IRRADIANCE: 16.5, UVA METER: 79, DISTANCE: 45 CM, IRRADIANCE: 30, UVA METER: 125, DISTANCE: 35 CM, IRRADIANCE: 39, UVA METER: 224. SPOTLIGHTS: BURTON HALOGEN, IRRADIANCE: 20, UVA METER: 70, DISTANCE: ISOLETTE, IRRADIANCE: 20, UVA METER: 0.02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA SPOTLIGHT LBI * NI NI
    2 BURTON HALOGEN SPOTLIGHT LBI * NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO