BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    !M1

    MDR report key: 9805187 · Received March 9, 2020

    Report

    Report Number
    3013677815-2020-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 9, 2020
    Manufacturer
    SOLUTIONS FOR TOMORROW AB
    Product Code
    IZL
    PMA / PMN Number
    K170607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A !M1 MOBILE X-RAY DEVICE HAD FOUND TO EMIT SMELL AND SMOKE. INVESTIGATION SHOWS THAT ONE CELL IN THE BATTERY VENTILATED. THIS IS A VERY RARE SITUATION, LESS THAN 0,00036 OCCASION IN THE BATTERY SERVICE LIFE. ALL IMPLEMENTED SAFETY MEASURES FUNCTIONED AS INTENDED AND THE DEVICE SHUT DOWN SAFTELY. THE SMOKE EMITTED HAS NO HEALTH EFFECTS ON PATIENTS, USERS OR ENVIRONMENT. A LITTLE AMOUNT OF ELECTROLYTE LEAKED ON THE BATTERY MOUNTING PLATE. THE MOUNTING PLATE CAN ONLY BE REACHED WHEN CONDUCTING SERVICE/MAINTENANCE ON THE DEVICE (ONLY AUTHORIZED SERVICE TECHNICIANS ARE ALLOWED TO PERFORM MAINTENANCE). A SERVICE BULLETIN IS SENT OUT TO INFORM ABOUT USE OF APPROPRIATE PROTECTIVE CLOTHING WHEN EXCHANGE OF BATTERY AT SUSPICIOUS ELECTROLYTIC LEAKAGE. PROTECTIVE -GLOVES, -EYEGLASSES, AND -COAT. EVENTUAL ELECTROLYTE HAS TO BE REMOVED WIPED UP AND DISCARDED IN A COVERED GARBAGE CAN. THERE ARE IN TOTAL (B)(4) UNITS IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE DEVICE WAS SITUATED IN AN OPEN AREA IN A CORRIDOR. WHILE CHARGING THE DEVICE EMITTED SMOKE. THE PERSONNEL MOVED THE DEVICE IN A NEARBY FREE AIRY ENVIRONMENT. THE SMOKE FROM THE DEVICE CEASED AFTER A FEW MINUTES.

    Additional Manufacturer Narrative · 1

    INITIAL EVALUATIONS SHOWS THAT ALL IMPLEMENTED SAFETY MEASURES HAS WORKED AS INTENDED. THE DEVICE SHUT DOWN SAFELY. THEORETICALLY CALCULATIONS SHOWS THAT THE GAS EMITTED HAS NO HEALTH EFFECTS ON PATIENTS, USERS OR THE ENVIRONMENT.

    Description of Event or Problem · 1

    THE DEVICE WAS SITUATED IN AN OPEN AREA IN A CORRIDOR. WHILE CHARGING THE DEVICE EMITTED SMOKE. THE PERSONNEL MOVED THE DEVICE IN A NEARBY FREE AIRY ENVIRONMENT. THE SMOKE FROM THE DEVICE CEASED AFTER A FEW MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270879 !M1 !M1 MODELONE IZL SOLUTIONS FOR TOMORROW AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other