MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-05 for COMPEX 11-2137 manufactured by Djo, Llc.
[122869558]
Serial number: requested, but unavailable.
Patient Sequence No: 1, Text Type: N, H10
[122869559]
It was reported that there was a shortage in the compex device that caused it to catch fire and spread to the end user's kitchen table. The device was stored in the box it came in with the pads and instructional paper on top of the end user's kitchen table. The device was charged beforehand, but it was disconnected while in the box. Nothing was burned besides the kitchen table, but a lot of smoke spread throughout the house. No one was at the house during the accident except for the end user's dog, whom a veterinarian confirmed was unharmed. Firefighters were called to the scene to extinguish the fire. The involved fire department is reportedly unable to return the device.
Patient Sequence No: 1, Text Type: D, B5
[127274846]
The report from the responding fire department states "it appeared fire started from faulty electro muscle stimulator inside a box with papers. " however, there is no evidence that a technical investigation of the device was performed. The device is not available for investigation. The end user originally stated the fire department took the device. However, when contacting the fire department, djo was informed that the device was not removed from the end user's home. The end user was then contacted and stated that the device was removed by the cleaning company and subsequently discarded. A root cause of the fire cannot be determined, nor can it be conclusively traced to the compex unit. The risk documentation and safety certifications were reviewed and found to be acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012446970-2018-00007 |
| MDR Report Key | 7939691 |
| Report Source | CONSUMER |
| Date Received | 2018-10-05 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-10-05 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 3151 SCOTT STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920819663 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPEX |
| Generic Name | STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING |
| Product Code | NGX |
| Date Received | 2018-10-05 |
| Model Number | 11-2137 |
| 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 | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |