MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for TEC 850 1177-9850-SEV manufactured by Datex-ohmeda, Inc..
[144848222]
For this event, ge healthcare? 's investigation into the reported occurrence is ongoing. A follow-up summary report will be issued when the investigation has been completed. No patient information available. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[144848223]
This report summarizes 1 malfunction event. A review of the event indicated that model 1177-9850-sev vaporizer experienced low output. It was reported that when the unit was set at 4%, it reads at 1. 5% causing the patient to wake up during surgery. There was no report of patient injury or recall. The report was received from a single source. The reported event did involve a patient. There was no patient information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2019-00178 |
| MDR Report Key | 8537431 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-06-05 |
| Date Mfgr Received | 2019-06-03 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 0 |
| Brand Name | TEC 850 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2019-04-22 |
| Model Number | 1177-9850-SEV |
| 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 | 2019-04-22 |