MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-14 for ACIST NAVVUS 014667 manufactured by Acist Medical Systems, Inc..
| Report Number | 2134243-2019-00015 |
| MDR Report Key | 8700549 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-14 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-06-14 |
| 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 | JEFF AUDRITSH |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9529959347 |
| Manufacturer G1 | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55344 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACIST |
| Generic Name | CATHETER, PRESSURE MONITORING, CARDIAC |
| Product Code | OBI |
| Date Received | 2019-06-14 |
| Model Number | NAVVUS |
| Catalog Number | 014667 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 7905 FULLER ROAD EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-06-14 |