BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOVI SCANNER

    MDR report key: 7826604 · Received August 29, 2018

    Report

    Report Number
    3014545134-2018-00104
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    April 4, 2018
    Report Date
    August 27, 2018
    Manufacturer
    ITOVI
    Product Code
    GZO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    0000000-06/08/18-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER ESTABLISHMENT: ITOVI (B)(4), DATE OF REGISTRATION STATUS: 2018, (B)(4), CLASSIFICATION NAME: DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT, PRODUCT CODE: GZO, DEVICE CLASS: 2, REGULATION NUMBER: 882.1540, MEDICAL SPECIALTY: NEUROLOGY, REGISTERED ESTABLISHMENT NAME: ITOVI, OWNER/OPERATOR: ITOVI, (B)(4), ESTABLISHMENT OPERATIONS: MANUFACTURER. COMPLAINT FILE ESTABLISHMENT FOR SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER ESTABLISHMENT: HUDSON SCIENTIFIC LLC (B)(4), STATUS: ACTIVE. *NOTE FIRM MAY HAVE ADDITIONAL ESTABLISHMENT TYPES. PLEASE REVIEW LISTINGS FOR FURTHER INFORMATION. DATE OF REGISTRATION STATUS: 2018. OWNER/OPERATOR: HUDSON SCIENTIFIC LLC, (B)(4). ESTABLISHMENT OPERATIONS: COMPLAINT FILE ESTABLISHMENT. SPECIFICATION DEVELOPER AND FINISHED PRODUCT MANUFACTURER IS IN THE PROCESS OF REDESIGNING A NEW MEDICAL DEVICE FOR SUBSEQUENT REPLACEMENT. MW5078263.PDF.

    Description of Event or Problem · 1

    USING A REPORTING LINK IN THE RECALL WEBSITE ESTABLISHED BY THE DEVICE SPEC. HOLDER, THE CUSTOMER WAS DIRECTED TO THE MEDWATCH WEBSITE. ON JULY 5TH, 2018, USING THE LINK, THE CUSTOMER REPORTED THAT: ON (B)(6) 2018: "GOT A ZAP FROM THE SCANNER." " SUSPECT: YES; PRIMARY: YES; DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OF STOPPED TAKING OR USING THE PRODUCT: YES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672063 ITOVI SCANNER ITOVI SCANNER GZO ITOVI ITS15 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR