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 2016-03-23 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[40954199]
Further inspection of the unit revealed that the interlock plunger pin and circlip were not in their proper position. Due to the age of the unit, the vaporizer has been scraped. No report of patient involvement.
Patient Sequence No: 1, Text Type: N, H10
[40954200]
During testing of the unit at the manufacturing site, it was noted that the interlock system was not functioning. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2016-00542 |
| MDR Report Key | 5519579 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 2005-05-13 |
| Date Added to Maude | 2016-03-23 |
| 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 | 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 6 PLUS |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2016-03-23 |
| 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 | 2016-03-23 |