BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 6100 SCANNER

    MDR report key: 2972618 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00022
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    ITX
    PMA / PMN Number
    K022153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE SHUT OFF DURING SCANS. THE BATTERY FAILED. THE SERVICE REPRESENTATIVE COULD NOT CONFIRM THE 0ML READING. THE SYSTEM WAS REPAIRABLE, BUT IT WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT READ ZERO. OTHER TIMES, IT WOULD SHUT OFF DURING A SCAN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69559 BVI 6100 SCANNER NONE ITX VERATHON MEDICAL 0570-0154

    Patients

    Seq Age Sex Outcome Treatment
    1