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 2018-08-30 for TEC 7 manufactured by Datex-ohmeda, Inc..
[118747227]
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The vaporizer was replaced. Patient information could not be obtained due to country privacy laws. (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
Patient Sequence No: 1, Text Type: N, H10
[118747228]
The hospital reported a light anesthesia case. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2018-01714 |
| MDR Report Key | 7832427 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-08-30 |
| 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 | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| 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 | 2018-08-30 |
| 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 DR, MADISON, WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-30 |