MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-15 for * HT1000R manufactured by Thermasolutions.
[2442363]
Sixty minutes into a ninety minute hyperthermic intraperitoneal chemoperfusion (hipec) procedure, the thermochem ht 1000r device stopped functioning. The device was on loan from the company thermasolutions. The following notice was on the video screen "no video input. " the video cable at the rear of the device was noticed to be defective and damaged. We called the company rep and took steps via phone instructions to bring the device back on line. The procedure was finished without further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2366898 |
| MDR Report Key | 2366898 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-11-03 |
| Report Date | 2011-11-15 |
| Date Reported to FDA | 2011-11-15 |
| Date Added to Maude | 2011-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | THERMOCHEM HT 1000R |
| Product Code | MLW |
| Date Received | 2011-11-15 |
| Model Number | HT1000R |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMASOLUTIONS |
| Manufacturer Address | 1889 BUERKLE ROAD BIRCHWOOD MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |