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 2017-11-08 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[91447085]
A gehc service representative performed a checkout of the equipment and confirmed the unit's output was low to manufacturer's specifications. The unit was returned to the manufacturing site for investigation. The unit was tested and the output was found to be high to manufacturing specifications. The reported fault was due to a damaged rotary valve. Patient information could not be obtained due to country privacy laws. 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
[91447086]
The hospital reported the patient woke up during a case. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2017-02088 |
| MDR Report Key | 7009677 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2012-01-03 |
| Date Added to Maude | 2017-11-08 |
| 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 | 540 W. NORTHWEST HIGHWAY |
| Manufacturer City | BARRINGTON IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEC 6 PLUS |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2017-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |