BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 6100 SCANNER

    MDR report key: 2961249 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00007
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K022153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE WAS CONFIRMED. THE PROBE READ HIGH/LOW AND WAS MAKING UNUSUAL NOISES DURING SCANS. ALSO THE DCM FAILED. THERE WAS NO EVIDENCE OF CUSTOMER DAMAGE. THE UNIT NEEDED TO BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS INACCURATE ON MULTIPLE PTS. THEY USED A CATHETER ON A PT TO CONFIRM THE INACCURACIES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53923 BVI 6100 SCANNER NONE IYO VERATHON MEDICAL 0570-0154

    Patients

    Seq Age Sex Outcome Treatment
    1