BEUDAMED
    FDA Adverse Event Summary report: N

    TOSHIBA

    MDR report key: 2800503 · Received October 22, 2012

    Report

    Report Number
    2020563-2012-00011
    Date Received
    October 22, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE -SYSTEM DOES NOT START FROM STANDBY MODE. IT WAS FOUND THAT THE SYSTEM HAS A LIMITATION THAT IT IS NOT POSSIBLE TO START THE POWER UNTIL APPROXIMATELY 5 SECONDS AFTER STANDBY LED LIGHTS (UNTIL THE INTERNAL CIRCUITS BECOME STABLE) AFTER THE AC PLUG IS INSERTED. IF THE POWER SWITCH IS PRESSED WITHIN THIS TIME (5 SECONDS),THE ATX UNIT JUDGES THAT THE POWER SUPPLY DOES NOT START UP AND IS ABNORMAL, AND THEN MAY FORCIBLY STOP THE POWER UNIT. THIS DOES NOT OCCUR WHEN THE POWER SWITCH IS PRESSED 15 SECONDS AFTER STANDBY LED LIGHTS PER THE OPERATION MANUAL. WE ARE IN THE PROCESS OF DETERMINING A COURSE OF ACTION TO TAKE TO FIX THESE ISSUES.

    Additional Manufacturer Narrative · 1

    CUSTOMERS HAVE BEEN NOTIFIED THAT THE SYSTEM DOES NOT START UP FROM THE BATTERY POWERED STANDBY MODE AND THAT IT WILL BE DISABLED TEMPORARILY BY A FIELD MODIFICATION INSTRUCTION. A DESIGN CHANGE IS CURRENTLY BEING CONDUCTED TO CORRECT THIS PROBLEM. WHEN IT IS COMPLETED ALL UNITS WILL BE RETROFITTED WITH THE CHANGE.

    Description of Event or Problem · 1

    SYSTEM WAS PUT INTO STANDBY AND WHEELED OVER TO ER FOR A SCAN, THE SYSTEM WAS PLUGGED IN AND WOULD NOT BOOT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA ULTRASONIC IMAGING SYSTEM IYN TOSHIBA MEDICAL SYSTEMS CORPORATION TUS-A500

    Patients

    Seq Age Sex Outcome Treatment
    1