ROSCOE
Received Jun 22, 2026
Report 3005170249-2026-00003 · MDR key 25573080
Device
Generic name
Quattro 2.5
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.Model number
DQ8450(MANUFACTURER# MT1023)Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Loss of consciousness
- Cramp(s) /Muscle Spasm(s)
Narrative
Additional Manufacturer Narrative
THIS EVENT WAS ALSO REPORTED TO FDA BY THE IMPORTER UNDER IMPORTER REPORT NO. (B)(4). 1) INVESTIGATION METHOD: THE DEVICE WAS NOT RETURNED, AND THE IMPORTER WAS UNABLE TO PERFORM TESTING. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. MEANWHILE, THE MANUFACTURER REQUESTED ADDITIONAL INFORMATION FROM THE IMPORTER AND REVIEWED THE DHR OF THE SAME BATCH. NO ABNORMALITIES WERE FOUND IN PRODUCTS FROM THE SAME BATCH. 2) FAILURE MODE/MECHANISM CONSIDERATION: THE USER REPORTED LOSS OF CONSCIOUSNESS AND CONVULSIONS AFTER USING THE DEVICE, BUT NO SPECIFIC DESCRIPTION OF THE DEVICE USE PROCESS WAS PROVIDED. THE CUSTOMER HAS BEEN REQUESTED TO PROVIDE ADDITIONAL INFORMATION. AT THE SAME TIME, OUTPUT TESTING WAS PERFORMED ON DEVICES OF THE SAME MODEL FROM DIFFERENT BATCHES. BASED ON OSCILLOSCOPE OBSERVATION, THE OUTPUT WAVEFORM AND OUTPUT VOLTAGE/CURRENT WERE WITHIN THE ALLOWABLE DEVIATION RANGE. NO DC COMPONENT WAS OBSERVED DURING POWER ON/OFF OR DURING OUTPUT. NO ABNORMAL INFORMATION WAS FOUND DURING THE REVIEW OF THE DHR OF THE COMPLAINT DEVICE. SPECIFIC TEST RESULTS CAN BE REFERENCED IN THE TEST REPORT. THERE HAVE BEEN NO SIMILAR PREVIOUS RECORDS OF THE ISSUE REPORTED BY THE CUSTOMER. THE CUSTOMER NEEDS TO PROVIDE DETAILED INFORMATION SUCH AS THE DEVICE USE PROCESS, WAVEFORM PARAMETERS, AND THE PATIENT'S MEDICAL TREATMENT STATUS. BASED ON THE CURRENTLY AVAILABLE INFORMATION, NO CAUSAL CONCLUSION CAN BE ESTABLISHED. 3) CONCLUSION: AT PRESENT, THERE IS NO EVIDENCE INDICATING THAT ABNORMAL DEVICE OUTPUT COULD HAVE CAUSED THE USER'S LOSS OF CONSCIOUSNESS AND CONVULSIONS. TEST RESULTS OF THE SAME MODEL DEVICES FROM DIFFERENT BATCHES WERE COMPLIANT. THE CUSTOMER FEEDBACK DID NOT MENTION BURNS, SUDDEN STRONG STIMULATION, FRIGHT, OR OTHER SIMILAR SITUATIONS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN THE EVENT AND DEVICE FAILURE CANNOT BE ESTABLISHED. THE POSSIBILITY OF THE USER'S UNDERLYING CONDITION OR INDIVIDUAL FACTORS IS MORE LIKELY, BUT FURTHER INFORMATION SUCH AS THE USE PROCESS, TREATMENT PARAMETERS, AND MEDICAL TREATMENT STATUS IS STILL REQUIRED FROM THE CUSTOMER.
Description of Event or Problem
THE DEVICE WAS BEING USED ON THE PATIENT FOR MAYBE 20-30 SECONDS, THE SETTING WAS AT 12. THE END USER PASSED OUT AND STARTED TO SPASM.