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 2017-11-13 for TEC 7 manufactured by Datex-ohmeda, Inc..
[92493887]
Vthe unit was returned to the gehc service center. Testing confirmed anesthetic agent output low to specification. The vaporizer was replaced. The customer contact reported there was no patient information available.
Patient Sequence No: 1, Text Type: N, H10
[92493888]
The hospital reported that, during a case, the patient started to move. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[132254813]
The unit was returned to the manufacturing site. The unit was tested and the output was found to be within published specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2112667-2017-02116 |
| MDR Report Key | 7024564 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-13 |
| Date of Report | 2018-03-28 |
| Date of Event | 2017-10-04 |
| Date Mfgr Received | 2018-03-01 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-11-13 |
| 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 | 2017-11-13 |
| Model Number | NA |
| Lot Number | BEJL07611 |
| ID Number | UDI_NOT_REQUIRED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |