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 2019-11-29 for IVENT 201 M1163923 manufactured by Datex-ohmeda, Inc..
| Report Number | 2112667-2019-02396 |
| MDR Report Key | 9391990 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2019-11-01 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-11-29 |
| 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 City | WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVENT 201 |
| Generic Name | CRITICAL CARE VENTILATER |
| Product Code | CBK |
| Date Received | 2019-11-29 |
| Model Number | M1163923 |
| 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 DR, MADISON, WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-29 |