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 2016-08-09 for TEC 7 manufactured by Datex-ohmeda, Inc..
[51744515]
Patient information could not be obtained after multiple attempts. Attempts were made as follows: 7/21/2016 - voicemail, 7/25/2016 - voicemail, 7/26/2016 - voicemail. A ge healthcare service representative performed a checkout of the system and found no issues with the anesthesia machine but confirmed an output issue with the tec 7 vaporizer. The defective vaporizer was removed from the anesthesia machine. Ge healthcare attempted to obtain the defective vaporizer for investigation but there has been no response to the requests.
Patient Sequence No: 1, Text Type: N, H10
[51744516]
The hospital reported difficulty was noted while sedating a patient for a case. The hospital's agent monitor was indicating lower anesthetic agent than what was dialed in on the vaporizer. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2016-01524 |
| MDR Report Key | 5862491 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-07-07 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2009-04-21 |
| Date Added to Maude | 2016-08-09 |
| 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 | JOSEPH SELIGA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| 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 7 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2016-08-09 |
| 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 | 2016-08-09 |