MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for TEC 6 PLUS 1107-9601-000 manufactured by Datex-ohmeda, Inc..
[143722945]
For this event, ge healthcare's investigation into the reported occurrence is ongoing. A follow-up summary report will be issued when the investigation has been completed. No patient information available after three attempts. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[143722946]
This report summarizes 1 malfunction event. A review of the event indicated that model 1107-9601-000 vaporizer ran out of anesthetic agent and did not alarm as intended resulting in light anesthesia. There was no report of patient injury or recall. The report was received from a single source. The reported event did involve a patient. There was no patient information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2019-00179 |
| MDR Report Key | 8544251 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-06-27 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-24 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 0 |
| Brand Name | TEC 6 PLUS |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2019-04-24 |
| Model Number | 1107-9601-000 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-24 |