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 2018-09-06 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[119370367]
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The vaporizer was replaced. The customer contact reports there is no patient information available.
Patient Sequence No: 1, Text Type: N, H10
[119370368]
The hospital reported the agent output was higher than expected. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2018-01757 |
| MDR Report Key | 7850458 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-08-16 |
| Device Manufacturer Date | 2001-07-18 |
| Date Added to Maude | 2018-09-06 |
| 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 | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| 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 | 2018-09-06 |
| 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 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |