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 2019-05-02 for TEC 850 1177-9850-SEV manufactured by Datex-ohmeda, Inc..
[143821120]
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. No patient information available at time of mdr filing. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[143821121]
The hospital reported that during the first use of this vaporizer toward the end of the case, the patient experienced hypertension and coded. The patient was stabilized and is reported to be alright now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2019-00183 |
| MDR Report Key | 8573188 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-02 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-05-02 |
| 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 850 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2019-05-02 |
| Model Number | 1177-9850-SEV |
| 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 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |