BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX FOCUS 800 SYSTEM

    MDR report key: 7133582 · Received December 20, 2017

    Report

    Report Number
    9680269-2017-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 15, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BK MEDICAL APS
    Product Code
    IYN
    UDI-DI
    05704916001025
    PMA / PMN Number
    K081154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS REPLACED WITH A LOANER UNIT. THE FACILITY WOULD NOT ALLOW THE SERVICE TECHNICIAN TO REMOVE THE DEVICE FROM THEIR PREMISES.

    Description of Event or Problem · 1

    IN THE OR DURING A ROBOTIC SURGERY CASE WITH THE USE OF THE BK MEDICAL ULTRASOUND SYSTEM AT APPROXIMATELY 10:30 AM, WITH THE ULTRASOUND PLUGGED INTO THE WALL, A NURSE NOTICED A NOISE AND SAW SMOKE COMING FROM THE BACK OF FLEX FOCUS 800 ULTRASOUND S/N (B)(4) WITH UA1214 KEYBOARD STAND S/N (B)(4). THE ORDERLY IMMEDIATELY UNPLUGGED THE UNIT FROM THE WALL AND BROUGHT INTO THE HALLWAY. AT THIS TIME, THE UNIT WAS STILL SMOKING AND THE ORDERLY USED A WATER FIRE EXTINGUISHER ON THE ULTRASOUND CONCENTRATING ON THE BATTERY BAY AREA ON THE UA1214. NEXT A FIRE ALARM WAS PULLED AND THE BIO-MED TECH SHOWED UP WITH A REPLACEMENT FLEX 800. THE BIO-MED TECH SAW THE BATTERIES CATCH FIRE WHEN THE WATER WAS APPLIED. THE FIRE DID GO OUT AFTER A SHORT TIME. WHEN THE FIRE DEPT. SHOWED UP THE FIRE WAS OUT. THEY REMOVED THE EQUIPMENT AND BROUGHT IT DOWN TO THE BIO-MED SHOP. THE BIO-MED ENGINEER DID NOT KNOW THE STATUS OF THE CHARGE BEFORE INCIDENT. THEY DID SAY THE NURSES SAW THE WARNING TO REPLACE THE BATTERIES ON THE SCREEN. THE BIOMED DEPARTMENT HAD JUST ORDERED 6 NEW BATTERIES TO REPLACE ON ALL 3 ULTRASOUNDS BUT DID NOT HAVE A CHANCE TO REPLACE ON THIS UNIT YET. THEY WERE NOT AWARE THERE WERE 4 BATTERIES IN THIS UNIT WHEN HE ORDERED THEM. BIO-MED HAD NO KNOWLEDGE OF DAMAGE TO THE BATTERIES OR THE ULTRASOUND BEFORE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915750 FLEX FOCUS 800 SYSTEM ULTRASOUND PULSED DOPPLER IMAGING SYSTEM IYN BK MEDICAL APS FLEX FOCUS 800 SYSTEM N/A 05704916001025

    Patients

    Seq Age Sex Outcome Treatment
    1