MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD COMPASS HEALTH BRANDS; THERATOUCH CX4

Model Number DQ8200

Device Problem Output Problem (3005)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

Customer states unit caused a burn on a residents lower back.Customer wanted to make note that at the time of the incident, the machine turned itself off and showed an error message.Looking at the manual, i believe it was the error, "the output current exceeds the setting current value." i had not seen this error code before.After seeing this message, the device was restarted and the treatment was continued for 8 more minutes at 53v.When the electrode pads were removed, there was no evidence of abnormality on the skin.The electrodes used were valutrode, ref #cf5050.They also wanted to emphasize that the pack was new for that treatment.The machine was operated by a physical therapist.Relevant medical conditions: s/p cervical and lumbar laminectomies w/ history of sever stenosis c2-c5.The burns are described as '4 full-thickness burns under placement of electrodes.The interferential waveform was being used at intensity of 64 milliamps with no modulated pulse.The leads had not been replaced in the last 6 months.No ointment or solvent was applied prior to electrodes.The device was powered down when the electrodes were moved.The have read the instruction manual.The burns are ongoing, 2 weeks, and the patient was referred to a wound specialist by a nurse.They were using 4 electrodes that were about 4 inches apart.Further clarifies the setting as '64v at preset settings: 80hz - 150hz for 1 minute.The patient did not have metal implants, as far as the end user is aware.'the electrodes used were 2" x 2" cloth square valutrode electrodes.All four were placed 1.5" bilaterally of the spinal column at level l3-l5, approximately 3 inches apart vertically.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: THERATOUCH CX4
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD; no. 3 building xilibaimang xus; estate, nanshan, shenzhen; shenzhen guangdong, 51810 8; CH 518108
• MDR Report Key: 11939198
• MDR Text Key: 254279426
• Report Number: 3012316249-2021-00019
• 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
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DQ8200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2021
• Distributor Facility Aware Date: 05/14/2021
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 06/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 84