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 |