BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT BVI6400 SCANNER

    MDR report key: 2972617 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00021
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE SCANNER DID NOT SCAN AND ALL BUTTONS WERE UNRESPONSIVE. THE SCANNER LOST SOFTWARE DUE TO A HARD RESET. THE SOFTWARE WAS RELOADED AND A NEW BATTERY WAS ADDED TO THE DEVICE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT TURN ON OR SCAN. THE UNIT HAD A BATTERY ICON AND LEVEL INDICATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69586 REPLACEMENT BVI6400 SCANNER NONE CCW VERATHON MEDICAL R570-0167

    Patients

    Seq Age Sex Outcome Treatment
    1