MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for STAT PROFILE PRIME PLUS ANALYZER SYSTEM 57400 manufactured by Nova Biomedical Corp.
| Report Number | 1219029-2019-00047 |
| MDR Report Key | 8959572 |
| Date Received | 2019-09-04 |
| Date of Report | 2019-10-02 |
| Date of Event | 2019-08-04 |
| Date Mfgr Received | 2019-08-06 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2019-09-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARIYA CESNULEVICIUS |
| Manufacturer Street | 200 PROSPECT ST. |
| Manufacturer City | WALTHAM MA 024543654 |
| Manufacturer Country | US |
| Manufacturer Postal | 024543654 |
| Manufacturer Phone | 7816473700 |
| Manufacturer G1 | NOVA BIOMEDICAL CORP |
| Manufacturer Street | 200 PROSPECT ST. |
| Manufacturer City | WALTHAM MA 024543654 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 024543654 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STAT PROFILE PRIME PLUS ANALYZER SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JFP |
| Date Received | 2019-09-04 |
| Model Number | 57400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORP |
| Manufacturer Address | 200 PROSPECT ST. WALTHAM MA 024543654 US 024543654 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-04 |