MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-29 for TEC 7 manufactured by Datex-ohmeda, Inc..
[39238748]
Patient information could not be obtained due to country privacy laws. Initial reporter: the initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Despite attempts to obtain the vaporizer for investigation, no response has been received. The exact root cause of the reported complaint cannot be determined without the vaporizer.
Patient Sequence No: 1, Text Type: N, H10
[39238749]
The hospital reported that, during a case, the patient exhibited signs of insufficient anesthesia. The clinician reportedly replaced the vaporizer and continued the case with no further reported complaint. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2016-00385 |
| MDR Report Key | 5466546 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-29 |
| Date of Event | 2015-11-03 |
| Date Mfgr Received | 2015-11-03 |
| Device Manufacturer Date | 2015-06-03 |
| Date Added to Maude | 2016-02-29 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE CASS |
| Manufacturer Street | 3000 N. GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI 531881696 |
| Manufacturer Country | US |
| Manufacturer Postal | 531881696 |
| 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 | 2016-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-29 |