MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-22 for THERMOCHEM HT 1000R HT-1000 manufactured by Thermasolutions.
[2397229]
Device usage problem device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
[9682201]
The ht-1000 was returned to our facility. The device was tested for proper voltage levels and the levels were correct. The device was placed into a test mode to run all parameters to their limits. Again, the device operated in spec. The "error" reported was not able to be duplicated. The device performs in specification and was returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005699784-2011-00002 |
| MDR Report Key | 2393953 |
| Report Source | 07 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-11-10 |
| Report Date | 2011-11-01 |
| Date Reported to FDA | 2011-11-01 |
| Date Mfgr Received | 2011-11-29 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1889 BUERKLE RD |
| Manufacturer City | BEAR LAKE MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal | 55110 |
| Manufacturer Phone | 6512093900 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOCHEM |
| Generic Name | THERMOCHEM HT1000R |
| Product Code | MLW |
| Date Received | 2011-12-22 |
| Returned To Mfg | 2011-11-17 |
| Model Number | HT 1000R |
| Catalog Number | HT-1000 |
| Lot Number | NONE |
| ID Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMASOLUTIONS |
| Manufacturer Address | 1889 BUERKLE RD BIRCHWOOD MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-22 |