MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. COMPASS HEALTH BRANDS; THERATOUCH EX4

Model Number DQ7200

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

The pt used this at the clinic and they have had it 2 years.They were using 4 dura stick plus 2" squares on clean skin surrounding the knee more then 4 inches apart.The elecrtrodes had been used 2 or 3 time prior to injury.The device was shut off before the electrodes were removed or adjusted.They were using ifc 4 pole continuous and no burn marks show up until later.They have not fully healed yet.The patient did seek medical attention there were 4 electrodes used above and below the knee joint, medially, and laterally (bracketing the knee joint) in an x pattern with the 2 channels.The ice pack was placed on top of the knee joint, which did cover the electrodes.We use this set-up all the time with our patients without a problem.We used this same machine on a different patient and there was a burning smell coming out of the machine, so we didn't complete the set up and put the unit out of service.Trigger word form information: the patient was a 76 year old male with no pre-existing conditions.An ice pack was used at the time of event.Burn marks showed up later.Was used on ifc - continuous, no modulating.They are unsure if leads/cables have been replaced within 6 months.They are using 2" square self adhesive electrodes surrounding knee - 4" distance, 4 in total.Used 2-3 times prior to injury.Nothing was applied to the skin prior and the device was turned off when pads were removed/adjusted.Skin was clear.Burns appeared several days later.They are ongoing, not fully healed.Patient did seek medical attention.Electrodes are not shared between patients.They are stored in a container packaged in original package.Patient is allergic to sulfa drugs.Pulse rate was 80-150 hz.They were not using the electrodes supplied with the device, they are using 2" square dura stick plus electrodes.They are "unsure - changed out in the past" when asked if they have tried new lead wires.They state "no - lead wires were intact" when asked if any sign of damage.

Event Description

Device was returned for inspection, report attached.Findings are as follows: the reported problem could not be verified, the device was tested and passed all functional tests with no problems found, no accessories were received so they could not be tested.Device was tested on all stim treatments for several hours with no problems.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: THERATOUCH EX4
• 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: 17037045
• MDR Text Key: 316284589
• Report Number: 3012316249-2023-00014
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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: DQ7200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2023
• Distributor Facility Aware Date: 05/08/2023
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male