MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-08 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[74625397]
Patient Sequence No: 1, Text Type: N, H10
[74625398]
Premature number wear on anesthesia vaporizers; cause unsure level on gas mix. This is a recurring event; 4 have been replaced since the beginning of the year. A suggestion: there should be some film or coating over the numbers so they should not be able to be rubbed off so easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6551081 |
| MDR Report Key | 6551081 |
| Date Received | 2017-05-08 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-01-30 |
| Report Date | 2017-02-09 |
| Date Reported to FDA | 2017-02-09 |
| Date Reported to Mfgr | 2017-02-09 |
| Date Added to Maude | 2017-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEC 6 PLUS |
| Generic Name | VAPORIZER, ANESTHESIA |
| Product Code | CAD |
| Date Received | 2017-05-08 |
| ID Number | X1107-9601-000 |
| Device Availability | Y |
| 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 | 2017-05-08 |