MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-21 for INTENSITY 10 DIGITAL TENS INTENSITY 10 (DI1010) manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[131938171]
By analyzing the circuit design of di1010, the component that causes explosion is capacitors and battery. We conducted a principle analysis of the possibility of explosion of capacitors and battery, eliminating the possibility of capacitors and confirming the explosion caused by the battery. Csr team feedback the end user using the "green" battery , but we checked the outer skin of the battery (tens cell) is ocher. And also, from the photo on the scene, after the explosion, we can found the colors of the battery that removing the outer skin packaging is silver. But the tens cell battery is black. Based on the above analysis, the end user using the other brand battery to supply device cause this explosion and don't follow up the instruction manual cautions. During the pages of the 15, sections 4. 1 battery cautions, we recommends the user replace the same type battery. We checked csr team to help to ask the end user for battery information and samples for further analysis, but up till now, we can not get it.
Patient Sequence No: 1, Text Type: N, H10
[131938172]
Customer stated that his tens unit exploded while he was using it to treat his persistent neck pain. The explosion occurred at 3 am on the morning of monday, (b)(6) 2018 in the bedroom of his residence. He states that he has police and fire department reports. He states that he was awakened in the wee-hours by neck pain, and proceeded to apply the leads to the painful area (the approximate sites shown in the upper pair of electrodes in option 1 of the illustration for neck pain placement which accompanied the device and instructions). He turned the time to c, and then the intensity to 12, settings he had previously used many times with considerable benefit. While he did not record the exact time he applied the device, he would estimate it to have been around 1:30 am. He then started to read his recent issue of the economist, while waiting for the pain to diminish to a level where sleep was possible - bu the ensuing bang! , flash of flames and billowing, acrid smoke dashed any hope of sleep for the rest of the night! As soon as he had extinguished the flames, which he states took 30+- seconds, and opened windows to clear the room of smoke, he called 911 and the fire department responded within minutes, the police minutes later. The device was about 1/3 destroyed: what wasn't destroyed was severely scorched, and molten case and wires were blown some distance from the site of the actual explosion, 1/2 of the partially melted battery was imbedded in the carpet about 4 feet away. While he states he was only the length of the electrode wires away from the device when it blew, he was not seriously injured. He reports an "acid burn" on the lower part of his right arm, according to the fire chief.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2018-00009 |
| MDR Report Key | 8188569 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-21 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-03-13 |
| Date Added to Maude | 2018-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS |
| Manufacturer Street | BLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD |
| Manufacturer City | SHENZHEN, GUANGDONG 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTENSITY 10 DIGITAL TENS |
| Generic Name | TENS UNIT |
| Product Code | GZJ |
| Date Received | 2018-12-21 |
| Model Number | INTENSITY 10 (DI1010) |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Address | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,NANSHAN SHENZHEN, GUANGDONG 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |