MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-05 for TEC 7 manufactured by Datex-ohmeda, Inc..
[56454332]
Ge healthcare? S investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[56454333]
The hospital reported that, during a case, the patient started to wake up. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[61521015]
The unit was returned to the manufacturing site for investigation. The unit was tested and found to function within manufacturer? S specifications. The reported complaint could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2112667-2016-01948 |
| MDR Report Key | 5999523 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-05 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2016-10-05 |
| 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 | JOHN SZALINSKI |
| Manufacturer Street | 540 W. NORTHWEST HIGHWAY |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer G1 | DATEX-OHMEDA, INC. |
| Manufacturer Street | 3030 OHMEDA DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEC 7 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2016-10-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-05 |