MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. INTENSITY; CX4 PROFESSIONAL

Model Number DQ8000

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)

Patient Problems Superficial (First Degree) Burn (2685); Full thickness (Third Degree) Burn (2696)

Event Date 10/10/2022

Event Type  Injury  

Event Description

We hooked a patient up a few weeks ago.The patient told them to keep turning it up, they couldn't feel it, which resulted in 3rd degree burns.The low pads were 1st degree the lower pads are 3rd degree and he also no longer has no nerve ending.He is not ok but he is not hospitalized.Unit has been used since around 2018.The patient did not have access to the safety stop switch and the clinic is not sure that this is something that they currently have.Information from the word trigger form: device was being used in a chiropractors office by a chiropractor aid.The end user is a male, 28 years old, about 220 lbs and 5'11".Device is 7 years old and has been in use since 2018 according to the clinic.There were no other devices being used at the time of the event.The burns showed up immediately after treatment.They were using 4 electrodes in a criss-cross pattern.A modulating program was being used, the acute therapy program.The lead wires were replaced either this year or last year they are not exactly sure.(4) 2x2 self adhesive electrodes were used, they are not sure if they are new or had previous use, they were placed about 5 inches apart, and being used on the lower back.No conductive spray or solvent was used.Electrodes are not being shared between patients.An alcohol pad was used and dried completely before placing electrodes.Electrodes were placed on clear skin.The burn is still presents after 2 weeks.The burn happened on (b)(6) 2022.The burn is still present but the patient did not show back up for their appointment.The chiropractor does not have the medical records from the emergency room but may be able to obtain them.Electrodes are stored in their bag in a cabinet in-between uses.Compass health electrdoes, part # ef2020wf2 are being used.There are no exposed wires or damage noted on the lead wires.Patient has no known allergies.Ifc-4p was being used with a pulse rate of 80/150 and the frequency modulation was 10,000hz.Customer does not know what channels this was happening on.The likely root cause of this event was determined to be user error because the customer did not provide the patient with the kill switch and the device was set to the highests frequency modulation setting.They do not know if the lead wires have been replaced; these require replacement at least yearly.

• Brand Name: INTENSITY
• Type of Device: CX4 PROFESSIONAL
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; floor 1-2, no.3 building, fans; industrial estate xilixiaobaim; shenzhen guangdong, 51810 8; CH 518108
• MDR Report Key: 15789662
• MDR Text Key: 303580349
• Report Number: 3012316249-2022-00014
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DQ8000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Distributor Facility Aware Date: 10/24/2022
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 100 KG