MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-20 for RICHMAR HT-R12-D manufactured by Compass Health Brands.
[183896209]
The fuse area had a melt down. Per picture provided by customer, the fuse area is blackened and some wires have melted/black spots on wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2020-00009 |
| MDR Report Key | 9732220 |
| Report Source | CONSUMER |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2020-02-20 |
| 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 | CYNTHIA TONEY |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS, |
| Manufacturer Country | US |
| Manufacturer Phone | 2682110 |
| Manufacturer G1 | COMPASS HEALTH BRANDS |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS, |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICHMAR |
| Generic Name | HYDRA THERM DLX |
| Product Code | IRQ |
| Date Received | 2020-02-20 |
| Model Number | HT-R12-D |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPASS HEALTH BRANDS |
| Manufacturer Address | 6753 ENGLE ROAD MIDDLEBURG HEIGHTS, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |