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 HT1000R HT-1000 manufactured by Thermasolutions.
[2371012]
Title: xxxxx. Event desc: 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. Device usage problem: other.
Patient Sequence No: 1, Text Type: D, B5
[9682200]
A service engineer went to the location after the case. The service engineer replaced the over temperature switch and then evaluated and adjusted voltage levels. The device was then run through an installation process to confirm the repairs corrected the issue reported by the customer. The device was operating properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005699784-2011-00001 |
| MDR Report Key | 2393952 |
| Report Source | 07 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-11-03 |
| 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 | 2012-07-26 |
| 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 | WHITE 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 HT 1000R |
| Product Code | MLW |
| Date Received | 2011-12-22 |
| Returned To Mfg | 2011-11-17 |
| Model Number | HT1000R |
| Catalog Number | HT-1000 |
| Lot Number | NONE |
| ID Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 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 | 1. Other | 2011-12-22 |