BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDERSCAN BVI 3000 BATTERY CHARGER

    MDR report key: 6730833 · Received July 20, 2017

    Report

    Report Number
    3022472-2017-00008
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 5, 2017
    Report Date
    June 28, 2017
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K915436
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION EXHIBITED CONFIRMED THAT BOTH INTERNAL SURFACES OF THE POWER SUPPLY AND THE INTERNAL COMPONENTS WERE COVERED WITH SIGNIFICANT AMOUNT OF DUST/DEBRIS. ADDITIONALLY, THE DEVICE WAS FOUND TO HAVE A BURNED AREA ON THE PRINTED CIRCUIT BOARD (PCB) WHICH WOULD HAVE CAUSED SMOKE TO EMANATE FROM THE DEVICE. INVESTIGATION RESULTS CONCLUDED THAT THIS MALFUNCTION WAS LIKELY A RESULT OF EXCESSIVE HEAT GENERATED FROM THE CONDUCTIVE TRACES, IN THE PCB THAT CREATED ABNORMALLY HIGH RESISTANCE THAT RESULTED EXCESS POWER DISSIPATION (SMOKE). THE ABNORMALLY HIGH RESISTANCE WAS MOST LIKELY CAUSED BY THE INGRESS OF DUST, DIRT, AND OTHER FOREIGN OBJECT DEBRIS (FOD). POSSIBLE ROOT CAUSES OF THE USE OF CORROSIVE CLEANING SOLUTIONS OR AN ORIGINAL DEFECT IN THE COPPER TRACE COULD NOT BE RULED OUT DUE TO DAMAGE. THE AGE OF THE DEVICE (17 YEARS) WHICH IS 12 YEARS BEYOND THE EXPECTED DEVICE USE, LIKELY CONTRIBUTED TO THE EXCESSIVE ACCUMULATION OF FOD. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT THE REPORTED EVENT IS AN ISOLATED INCIDENT. NO REPORTS OF CHARGER SMOKING OR OTHER SIMILAR REPORTS HAVE BEEN REPORTED FOR THIS SPECIFIC MODEL OF POWER SUPPLY NOR WITH ANY OTHER POWER SUPPLIES USED IN CONJUNCTION WITH THE BLADDERSCAN 3000 CHARGER. THEREFORE, NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS REQUIRED. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE BLADDERS CAN 3000 BATTERY CHARGER WOULD BE RETURNED FOR EVALUATION, AT THE TIME OF THIS REPORT THE DEVICE IS REPORTED TO BE IN TRANSIT. VERATHON CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    VERATHON RECEIVED THE FOLLOWING INFORMATION ON A USER FACILITY MEDWATCH: "OUR SECURITY OFFICER WAS CONDUCTING FIRE WATCH PATROL IN THE FACILITY WHEN HE OBSERVED SMOKE (COMING) FROM A BATTERY CHARGING UNIT THAT WAS PLUGGED IN AT THE NURSE'S STATION. THE OFFICER ACTIVATED THE FIRE ALARM PULL AT THE STATION. STAFF AT THE NURSE'S STATION UNPLUGGED THE CHARGER AND THEN ANNOUNCED CODE RED. I RESPONDED TO THE SCENE ALONG WITH ADDITIONAL PERSONNEL. VALET CLEARED THE FRONT CIRCLE OF VEHICLES AND AN OFFICER WAS POSTED AT THE FRONT CIRCLE AWAITING THE ARRIVAL OF THE FIRE DEPARTMENT. AT APPROXIMATELY 1028, TWO FIRE PERSONNEL ARRIVED ON THE SCENE. THE FIREFIGHTERS REPORTED THAT THEY HAD COME IN THROUGH THE MRI ENTRANCE. AT THE SAME TIME, ADDITIONAL FIRE DEPARTMENT UNITS ARRIVED AT THE MAIN ENTRANCE AND WERE ESCORTED TO THE SCENE OF THE FIRE. THE FAULTY CHARGING UNIT WAS REMOVED BY FACILITIES AND THE AREA WAS CHECKED BY THE FIRE DEPARTMENT. THE ALARM WAS RESET. AT 1032, STAFF ANNOUNCED CODE RED ALL CLEAR. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508883 BLADDERSCAN BVI 3000 BATTERY CHARGER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VERATHON MEDICAL 0400-0036 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1