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 2018-08-10 for TEC 7 manufactured by Datex-ohmeda, Inc..
[116725180]
The hospital biomed tested the unit and found it to fail the low pressure leak test. The vaporizer was replaced. Patient information could not be obtained after multiple attempts. Attempts were made as follows: 07/30/18 phone call, 08/07/18 phone call, 08/08/18 phone call.
Patient Sequence No: 1, Text Type: N, H10
[116725181]
The hospital reported that, during a case, higher than expected level of carbon dioxide was noted. Clinician reportedly had to increase level of anesthetic agent to maintain level of anesthesia. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2018-01585 |
| MDR Report Key | 7772026 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-07-14 |
| Date Mfgr Received | 2018-07-14 |
| Device Manufacturer Date | 2010-05-21 |
| Date Added to Maude | 2018-08-10 |
| 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 7 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2018-08-10 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-10 |