MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-21 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[33966389]
No report of patient involvement. The unit was returned to ge healthcare for investigation. The unit was inspected and it was noted that the interlock rod assembly was missing.
Patient Sequence No: 1, Text Type: N, H10
[33966390]
While testing the unit at the service depot facility, it was noted that the interlock system was not functioning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2015-00411 |
| MDR Report Key | 5313365 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-21 |
| Date of Report | 2015-11-02 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2015-11-02 |
| Device Manufacturer Date | 2014-07-31 |
| Date Added to Maude | 2015-12-21 |
| 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 | 2015-12-21 |
| 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 | 2015-12-21 |