BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT®

    MDR report key: 13497388 · Received February 9, 2022

    Report

    Report Number
    13497388
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 10, 2022
    Manufacturer
    CIANNA MEDICAL, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SCOUT PROBE DEFECTIVE WHEN PLUGGED INTO MACHINE. THE PROBE WE HAD ORIGINALLY OPENED SAID "CHECK CONNECTION" AND WE TRIED TURNING THE MACHINE OFF AND RE-PLUGGING THE PROBE BUT IT KEPT GIVING US THE SAME MASSAGE. WE OPENED A NEW PROBE AND THE SAVI WORKED JUST FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920588 SAVI SCOUT® MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL, INC. HPSU-01 H2225699

    Patients

    Seq Age Sex Outcome Treatment
    1 Female