MAUDE Adverse Event Report: ITOVI ITOVI SCANNER; GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO

Model Number ITS15

Device Problem Protective Measures Problem (3015)

Patient Problems Palpitations (2467); Electric Shock (2554)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

Specification developer and finished product manufacturer establishment: itovi (b)(4).Status: active; awaiting assignment of registration number; date of registration status: 2018; owner/operator: itovi (b)(4).Official correspondent: (b)(4), proprietary name: itovi; classification name: device, galvanic skin response measurement; product code: gzo; device class: 2; regulation number:(b)(4); medical specialty: neurology; [(b)(4)].

Event Description

From (b)(6) 2018- (b)(6) 2018, there were various discussions between the complainant and the formally designated complaint unit from the finished product manufacturer/ specification developer.During initial discussions on (b)(6) 2018, the complainant alleged to itovi's (the finished product manufacturer/ specification developer) formally designated complaint unit ((b)(4)) that on (b)(6) 2018, she (adult female) received an electric shock and heart palpitations (which also caused her to be passed out for an unknown amount of time also on (b)(6) 2018) while using the itovi device (i.E while scanning and having the unit be plugged into a power source).On (b)(6) 2018, the complainant sought medical attention due to the electric shock and heart palpitations.The subsequent (b)(6) 2018 medical record (copy supplied by the complainant) indicated that the complainant (who was alert and oriented three times) had lessening palpitations from the time of the incident, the complainant had no chest pain, coughing, dizziness, fever, malaise/fatigue, nausea, shortness of breath, vomiting or weakness during the (b)(6) 2018 medical examination.However, the medical record did not indicate whether the complainant required hospitalization and/or treatment for the alleged electric shock and heart palpitations.

• Brand Name: ITOVI SCANNER
• Type of Device: GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO
• Manufacturer (Section D): ITOVI; 355 south 520 west; suite 250; lindon 84042
• Manufacturer (Section G): ITOVI; 355 south 520 west; suite 250; lindon UT 84042
• Manufacturer Contact: michael wadman ; 355 s. 520 w; suite 250; lindon 84042 ; 8016150636
• MDR Report Key: 7670512
• MDR Text Key: 113499168
• Report Number: 3014545134-2018-00103
• Device Sequence Number: 1
• Product Code: GZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ITS15
• Device Lot Number: 092017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR