BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOBLUS ULTRASOUND SCANNER

    MDR report key: 6446683 · Received March 30, 2017

    Report

    Report Number
    9610865-2016-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 5, 2017
    Product Code
    IYO
    PMA / PMN Number
    K142368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOBLUS # (B)(4) (AC ADAPTER # (B)(4)) IN CARDIAC OFFICE . AC POWER ADAPTER MANUFACTURING ADDRESS AS FOLLOWS, (B)(4). THE AC POWER ADAPTOR USED WITH THE NOBLUS (K142368) ULTRASOUND SYSTEM IS AN "OUT OF THE BOX/OFF THE SHELF" EXTERNAL POWER SUPPLY. THE NOBLUS WAS NOT AFFECTED BY THE FAILURE OF THE AC POWER ADAPTER. THERE WAS NO PATIENT OR USER INJURY AND ONCE A REPLACEMENT AC POWER ADAPTER WAS PUT INTO PLACE THE NOBLUSE FUNCTIONED PER SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    ONE (1) AC POWER ADAPTER(S) - (AC ADAPTER SERIAL # (B)(4)) WITH NOBLUS SERIAL # (B)(4)) SMOLDERED, SMOKED AND PARTIALLY DAMAGE TO BOTH POWER ADAPTERS. NO DAMAGE TO THE ULTRASOUND SYSTEMS, BOTH UNITES WERE UNAFFECTED AND MEET SPECIFICATIONS. NO PATIENT OR USER INJURY. MANUFACTURER (XP POWER (KUNSHAN) LTD.) IS CURRENTLY INVESTIGATING ROOT CAUSE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230542 NOBLUS ULTRASOUND SCANNER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO

    Patients

    Seq Age Sex Outcome Treatment
    1