MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-26 for TOSCA SENSOR 92 5621000 manufactured by Radiometer Basel Ag.
| Report Number | 3002807968-2019-00027 |
| MDR Report Key | 8735497 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-26 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-06-07 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2015-10-26 |
| Date Added to Maude | 2019-06-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRISTOPH FEULNER |
| Manufacturer Street | AUSTRASSE 25 |
| Manufacturer City | BASEL, CH-4051 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-4051 |
| Manufacturer G1 | RADIOMETER BASEL AG |
| Manufacturer Street | AUSTRASSE 25 |
| Manufacturer City | BASEL, CH-4051 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSCA SENSOR 92 |
| Generic Name | TOSCA SENSOR 92 |
| Product Code | DPZ |
| Date Received | 2019-06-26 |
| Model Number | 5621000 |
| Catalog Number | 5621000 |
| Lot Number | 508131 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER BASEL AG |
| Manufacturer Address | AUSTRASSE 25 BASEL, CH-4051 SZ CH-4051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-26 |