MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-15 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[36081055]
No report of patient involvement. The unit was returned to the manufacturing site for investigation. Inspection of the unit revealed the e-clip fell off the pivot pin. The unit was discarded and not returned to service.
Patient Sequence No: 1, Text Type: N, H10
[36081056]
During testing of the unit at the ge healthcare service depot, it was noted that the interlock system was not functional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2016-00076 |
| MDR Report Key | 5369887 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-15 |
| Date of Report | 2016-01-15 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2015-12-22 |
| Device Manufacturer Date | 2007-04-03 |
| Date Added to Maude | 2016-01-15 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE CASS |
| Manufacturer Street | 3000 N. GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| 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 6 PLUS |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2016-01-15 |
| 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 DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-15 |