BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN 3D BLADDER SCANNER

    MDR report key: 23153075 · Received September 26, 2025

    Report

    Report Number
    3006540052-2025-00001
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 24, 2025
    Manufacturer
    MEDA CO., LTD.
    Product Code
    IYO
    PMA / PMN Number
    K113304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    WE INVESTIGATED AND ANALYZED THE BLADDER SCANNER (SERIAL NUMBER: (B)(6)) DESCRIBED IN THE MEDICAL DEVICE REPORT. THE INCIDENT OCCURRED IN THE UNOCCUPIED EQUIPMENT STORAGE ROOM AND WAS NOT INITIALLY WITNESSED UNTIL SMOKE WAS DETECTED AND AN ALARM WAS TRIGGERED. NO PATIENTS OR USERS WERE INJURED. AT THE TIME OF THE INCIDENT, THE BATTERY WAS BEING CHARGED AND AN INCOMPATIBLE CHARGER (16.8V, EXCEEDING THE DEVICE BATTERY'S ALLOWABLE VOLTAGE OF 12.6V) WAS MISTAKENLY USED. ACCORDING TO THE INVESTIGATION, THERE WERE SEVERAL MISTAKENLY PLUGGED CHARGERS OF THE SAME TYPE ON THE SHELF ABOVE THE DEVICE, BUT THE USER COULD NOT DETERMINE THE CHARGING DURATION OR WHETHER THIS WAS THE FIRST TIME THE INCOMPATIBLE CHARGER WAS USED WITH THIS DEVICE. REPEATED CHARGING WITH CHARGERS EXCEEDING THE DEVICE'S RATED INPUT VOLTAGE INCREASES THE PROBABILITY OF BATTERY MALFUNCTION, POTENTIALLY LEADING TO COMBUSTION. REGARDING MISUSE OF INCOMPATIBLE CHARGERS, THE COMPANY HAS IMPLEMENTED MULTIPLE MEASURES TO REMIND USERS TO USE DESIGNATED CHARGERS ONLY. THE USER MANUAL EXPLICITLY STATES: "DO NOT USE NON-INDICATED CHARGERS", AND "CHARGING IN ABNORMAL CONDITIONS WILL CAUSE THE BATTERY'S INTERNAL PROTECTION CIRCUIT AND ITS FUNCTION TO BE LOST OR ABNORMAL CHEMICAL REACTIONS, WHICH WILL DAMAGE THE BATTERY AND REDUCE ITS LIFE CYCLE, AND MAY CAUSE OVERHEATING, DISTORTION, SMOKING, OR BURNING." THE ATTACHED DOCUMENT, "QUICK START GUIDE", INCLUDES A SAFETY WARNING OF "DO NOT USE NON-INDICATED CHARGERS. CHARGING IN ABNORMAL CONDITIONS WILL CAUSE THE BATTERY'S INTERNAL PROTECTION CIRCUIT AND ITS FUNCTION TO BE LOST OR ABNORMAL CHEMICAL REACTIONS, WHICH WILL DAMAGE THE BATTERY AND REDUCE ITS LIFE CYCLE, AND MAY CAUSE OVER-HEATING, DISTORTION, SMOKING OR BURNING." ALSO, THERE IS A SAFETY WARNING MESSAGE INDICATING ALLOWABLE INPUT VOLTAGE AND CURRENT NEXT TO THE BATTERY CHARGING PORT OF THE DEVICE. AT THE SAME TIME, IN ORDER TO FURTHER REDUCE RISKS OF OVERVOLTAGE CHARGING, A DESIGN CHANGE WAS MADE IN APRIL 2021, ADDING A PROTECTIVE CIRCUIT TO THE BATTERY (WHICH ALREADY HAS OVERCHARGING AND OVERCURRENT PROTECTION MEASURES IN PLACE) TO FURTHER MITIGATE THE RISKS.

    Description of Event or Problem · 0

    ON AUGUST 29, 2025, WE RECEIVED A MEDICAL DEVICE REPORT (MW5175279) FORWARDED BY FDA'S MEDWATCH PROGRAM, CONCERNING A BATTERY FIRE IN A BLADDER SCANNER (SERIAL NUMBER: (B)(6)). THE INCIDENT OCCURRED WHILE THE BATTERY WAS BEING CHARGED BY A NON-ORIGINAL CHARGER. IT HAPPENED IN AN UNOCCUPIED EQUIPMENT STORAGE ROOM WITH NO INITIAL WITNESSES UNTIL SMOKE WAS DETECTED AND AN ALARM WAS TRIGGERED. NO PATIENT OR USER INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060117 PORTASCAN 3D BLADDER SCANNER ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO MEDA CO., LTD. PORTASCAN 3D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown