BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER SCANNER

    MDR report key: 10095197 · Received May 28, 2020

    Report

    Report Number
    3006540052-2020-00001
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    February 27, 2020
    Report Date
    April 27, 2020
    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 · 1

    WE WERE NOTIFIED BY DIRECT SUPPLY MANUFACTURING INC., OUR OEM PARTNER, OF A FIRE CAUGHT ON A BLADDER SCANNER WHILE BEING CHARGED (INITIAL REPORT NUMBER: MW5093543). AS THE ORIGINAL MANUFACTURER, WE IMMEDIATELY AND REPEATEDLY ASKED DIRECT SUPPLY UPON NOTIFICATION TO COORDINATE WITH ITS USER TO SHIP BACK THE DEVICE TOGETHER WITH ITS CHARGER THAT WAS USED TO CHARGE THE BATTERY, AS IT IS CRUCIAL TO INVESTIGATION AND CAUSE ANALYSIS OF THE INCIDENT. IN CASE OF CHARGER MALFUNCTION OR MISUSE OF CHARGER OTHER THAN THAT SUPPLIED BY THE MANUFACTURER, THE BATTERY MIGHT BE OVERCHARGED TO CAUSE THE FIRE. HOWEVER, WHEN WE RECEIVED THE DEVICE, WE FOUND NO CHARGER IN THE PACKAGE. THEREFORE, WE CAN'T DETERMINE IF IT IS THE CHARGER THAT CAUSED THE FIRE. THE SERIAL NUMBER INDICATES THAT THE DEVICE WAS PRODUCED IN JUNE, 2013, AND THE USER HAS NOT PURCHASED ANY NEW BATTERY FOR REPLACEMENT SINCE ITS INITIAL USE. UPON REVIEW OF PAST COMPLAINTS, NO REPORTS OF SIMILAR INCIDENTS HAVE BEEN RECEIVED SO FAR. WE WILL CONTINUE TO PAY CLOSE ATTENTION TO PRODUCT SAFETY WHEN THEY ARE PUT IN USE. BESIDES THE STIPULATED WARNINGS AGAINST USE OF ANY CHARGER OTHER THAN THAT SUPPLIED BY THE MANUFACTURER IN THE USER MANUAL, WE PLAN TO ADD SUPPLEMENTARY SAFETY INFORMATION TO RELEVANT DOCUMENTS AS PREVENTIVE ACTION, THAT IS, AS THE BATTERY WEARS OVER TIME AND ITS EFFICIENCY DECREASES, USERS SHALL REPLACE THE BATTERY ON A TIMELY BASIS SO AS TO MINIMIZE ITS POTENTIAL RISK. (THIS REPORT IS LATE DUE TO THE ESG ENROLLMENT PROCESS, SINCE OUR APPLICATION OF WEBTRADER ACCOUNT WAS JUST APPROVED.)

    Description of Event or Problem · 1

    BLADDER SCANNER CAUGHT ON FIRE WHILE CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558551 BLADDER SCANNER IYO MEDA CO., LTD. ABS-1 (MD-6000) JUNE 2013

    Patients

    Seq Age Sex Outcome Treatment
    1