BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLS-100 LED LIGHT SOURCE / BLS-1000 PORTABLE

    MDR report key: 3928198 · Received June 20, 2014

    Report

    Report Number
    2242464-2014-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 20, 2014
    Manufacturer
    VISION-SCIENCES, INC.
    Product Code
    EOB
    PMA / PMN Number
    K050972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO ADVERSE HEALTH CONSEQUENCES HAVE BEEN REPORTED FOR ANY OF THE COMPLAINTS, USER (NURSE) RECEIVED A MINOR THERMAL BURN, DESPITE THE EXTREME LOW OCCURRENCE RATE FOR THIS EVENT ((B)(4)). INITIAL INVESTIGATION SUGGESTS INCOMPATIBILITY BETWEEN THE CHARGER AND BATTERY; HOWEVER, TESTING IS STILL BEING PERFORMED TO CONFIRM INITIAL CONCLUSION. NON-CONFORMING REPORT ISSUED TO CHARGERS TO QUARANTINE ALL CHARGES IN STOCK. HOLD-SHIPMENT STATUS HAS BEEN PLACED ON CHARGERS. EXPECTED DATE FOR COMPLETION OF ADDITIONAL TESTING (FAILURE MODE) JULY 15TH, 2014. INITIAL ROOT CAUSE INVESTIGATION PERFORMED ON 06/06/2014 INDICATED THE FOLLOWING: DEVICE - ACCESSORY: BLS-1000: THE REMAINS OF THE BLS-1000, BATTERIES AND CHARGER WERE EXAMINED BY ENGINEERING ON 06/02/2014. REMAINS OF BLS-1000 (BODY) WERE STILL OPERATIONAL. CLOSE EXAMINATION OF THE REMAINS OF THE BLS-1000 BODY SHOW SHRED METAL SEVERELY FRACTURED INDICATING INTENSE PRESSURE BUILD-UP INSIDE THE BLS-1000 BODY RESULTING IN THE RUPTURE OF THE BATTERY COMPARTMENT WITH EXPULSION OF THE BATTERY AND THE CONTENTS. ACCESSORIES: BATTERY CHARGER AND LITHIUM-ION RECHARGEABLE BATTERIES: BATTERY CHARGER WAS EXAMINED AND WAS FOUND TO BE OPERATING NORMALLY. CONCLUSION: THE BATTERY WAS OVER-CHARGED BY THE VANSON V-95 CHARGER. CHARGER HAS BEEN FOUND NOT ADEQUATE TO HANDLE THE CHARGE FOR THIS BATTERY (EEMB LIR 17335). BATTERY SPECIFICATION CALLS FOR CHARGE UPPER LIMIT VOLTAGE OF 4.2 V AND THE VANSON CHARGER UPPER LIMIT VOLTAGE IS 4.45. INTERNAL (B)(4) ASSIGNED TO THE CASE (CURRENTLY IN INVESTIGATION STAGE). ADDITIONAL TESTING IS BEING PERFORMED TO DETERMINE REMEDIAL ACTION. EXPECTED DATE FOR COMPLETION OF ADDITIONAL TESTING (FAILURE MODE) JULY 15TH 2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014, VISION-SCIENCES INC RECEIVED A REPORT, FROM DISTRIBUTOR IN (B)(6), THAT ONE LIGHT SOURCE BLS-1000 (P/N 07-3050) HAS EXPLODED WHEN SWITCHED ON. THERE WAS NO PATIENT INVOLVED BUT THE NURSE PREPARING THE UNIT WAS SLIGHTLY BURNT AT HAND AND EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363113 BLS-100 LED LIGHT SOURCE / BLS-1000 PORTABLE BLS-1000 LED LIGHT SOURCE SET EOB VISION-SCIENCES, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA