MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for VANQUISH ME BY BTL 713-B-000913 manufactured by Btl Industries.
[75852307]
We own a vanquish me by (b)(4). The machine caught fire while treating a patient in (b)(6) of 2016. The building had to be evacuated, the fire department was called, and extensive smoke damage had to be cleaned up. (b)(4) (b)(6) to the patient to pay her off and required she sign a release of liability and a gag order. They took the machine for "repairs" for 2 weeks and returned the same machine with ashes and singe marks still on it. On (b)(6) 2017 the machine caught fire once again but in a new location of the machine. The manufacturer is claiming that no other issues have ever been reported with this model and refuses to exchange the machine and has demanded that we continue with our lease payments or they will confiscate the machine, even though we have already paid them (b)(6) already, but dr. (b)(6) feels that we are putting our patients, employees, and property at risk by continuing to operate this machine. We do not know what to do at this point and that is why we are reaching out to you. Any guidance will be appreciated. Thank you. Neither patient had any previous health issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070005 |
| MDR Report Key | 6587432 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-05-02 |
| Date Added to Maude | 2017-05-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANQUISH ME BY BTL |
| Generic Name | VANQUISH ME BY BTL STIMULATOR |
| Product Code | GEI |
| Date Received | 2017-05-23 |
| Model Number | 713-B-000913 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BTL INDUSTRIES |
| Manufacturer Address | FRAMINGHAM MA 01702 US 01702 |
| Brand Name | VANQUISH ME BY BTL |
| Generic Name | VANQUISH ME BY BTL STIMULATOR |
| Product Code | OLI |
| Date Received | 2017-05-23 |
| Model Number | 713-B-000913 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTL INDUSTRIES |
| Manufacturer Address | FRAMINGHAM MA 01702 US 01702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-23 |