MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-20 for THERMASOLUTIONS, INC. MT-1000 manufactured by Thermasolutions, Inc..
[65597091]
Temperature sensor error during set-up. Vendor discovered corrosion on internal thermostat located in water reservoir. Surgery could not be completed due to malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067378 |
| MDR Report Key | 6269558 |
| Date Received | 2017-01-20 |
| Date of Report | 2017-01-19 |
| Date of Event | 2017-01-17 |
| Date Added to Maude | 2017-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | THERMASOLUTIONS, INC. |
| Generic Name | THERMOCHEM HT-1000 |
| Product Code | MLW |
| Date Received | 2017-01-20 |
| Model Number | MT-1000 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMASOLUTIONS, INC. |
| Manufacturer Address | WHITE BEAR LAKE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-20 |