BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI 6100 SCANNER (REPLACEMENT)

    MDR report key: 2961236 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC
    Product Code
    ITX
    PMA / PMN Number
    K022153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT MEASURED 0ML. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55058 BVI 6100 SCANNER (REPLACEMENT) NONE ITX VERATHON MEDICAL (CANADA) ULC R570-0154

    Patients

    Seq Age Sex Outcome Treatment
    1