MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-14 for TEC 6 manufactured by Datex-ohmeda, Inc..
[35983724]
The unit was inspected and it was noted that the short interlock rod was missing. The unit was scraped and not returned to service. No report of patient involvement.
Patient Sequence No: 1, Text Type: N, H10
[35983725]
During servicing of the unit at the ge healthcare service depot, 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 | 2112667-2016-00061 |
| MDR Report Key | 5367154 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-14 |
| Date of Report | 2016-01-14 |
| Date of Event | 2015-10-29 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 1993-02-01 |
| Date Added to Maude | 2016-01-14 |
| 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 | BRAD WHEELER |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD., W450 |
| 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 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2016-01-14 |
| 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 | 2016-01-14 |