MAUDE Adverse Event Report: ITOVI ITOVI SCANNER

Model Number ITS15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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".

• Brand Name: ITOVI SCANNER
• Type of Device: ITOVI SCANNER
• Manufacturer (Section D): ITOVI; 355 south 520 west; suite 250; lindon UT 84042
• Manufacturer (Section G): ITOVI; 355 s. 520 w; suite 250; lindon UT 84042
• Manufacturer Contact: michael wadman ; 355 s. 520 w; suite 250; lindon, UT 84042 ; 8016150636
• MDR Report Key: 7826604
• MDR Text Key: 118579572
• Report Number: 3014545134-2018-00104
• Device Sequence Number: 1
• Product Code: GZO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ITS15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 0000000-06/08/18-001-R
• Patient Sequence Number: 1
• Patient Age: 35 YR