MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for SONICATOR PLUS 940 ME940 manufactured by Ito Co., Ltd. Tsukuba Factory.
[71830091]
The patient was treated with the subject device with quadrupole interference wave at 70ma output for fifteen minutes. The patient noticed a blister on the upper abdominal area after the treatment.
Patient Sequence No: 1, Text Type: D, B5
[74607581]
Upon receipt of the device involved in the adverse event, ito conducted a failure analysis of the returned device. Inspection of the main unit returned: high voltage test: passed. Measurement of leakage current: within the pre-defined specifications. Measurement of power input: within the pre-defined specifications. Measurement of output voltage: within the pre-defined specifications. Measurement of output current: within the pre-defined specifications. Measurement of frequence: within the pre-defined specifications. Measurement of protectional ground resistance: within the pre-defined specifications. Test on safety mechanism: passed. Test on over-current detection function: passed. Measurement of ultrasound output: within the pre-defined specifications. Test on led lamp: passed. Test on fan motor: passed. Test on buzzer: passed. Test on unit display: passed. Inspection of consumable accessories returned: inspection on viscosity of the electrode surface: deterioration observed. Conclusion: ito concluded based on the analysis that the electrodes with deteriorated surface may have resulted in the concentration of electric current, which caused the patient's burn. In order to prevent the recurrence, ito reminded the user to follow the instruction for use contained in the user manual including the replacement of electrodes before deterioration of the surface.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614750-2017-00008 |
| MDR Report Key | 6462422 |
| Date Received | 2017-04-05 |
| Date of Report | 2015-04-25 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-04-06 |
| Device Manufacturer Date | 2011-05-31 |
| Date Added to Maude | 2017-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH BLOCK |
| Manufacturer Street | 1201 RICHARDSON DR. SUITE 160 |
| Manufacturer City | RICHARDSON TX 75080 |
| Manufacturer Country | US |
| Manufacturer Postal | 75080 |
| Manufacturer Phone | 9724809554 |
| Manufacturer G1 | ITO CO., LTD. TSUKUBA FACTORY |
| Manufacturer Street | 3-39-14 UZURANO AMI-MACHI |
| Manufacturer City | INASHIKI-GUN, IBARAKI 300-0341 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 300-0341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICATOR PLUS 940 |
| Generic Name | STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
| Product Code | IMG |
| Date Received | 2017-04-05 |
| Returned To Mfg | 2017-01-19 |
| Model Number | ME940 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITO CO., LTD. TSUKUBA FACTORY |
| Manufacturer Address | 3-39-14 UZURANO AMI-MACHI INASHIKI-GUN, IBARAKI 300-0341 JA 300-0341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-05 |