MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-28 for INSTRUMENT MANAGER 8.16.20 manufactured by Data Innovations Llc.
| Report Number | 1225673-2020-00001 |
| MDR Report Key | 9771892 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-11-22 |
| Date Added to Maude | 2020-02-28 |
| 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 | MR DAVID RUSSO |
| Manufacturer Street | 120 KIMBALL AVE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON, VT |
| Manufacturer Country | US |
| Manufacturer Phone | 6582850 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTRUMENT MANAGER |
| Generic Name | CALCLUATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| Product Code | JQP |
| Date Received | 2020-02-28 |
| Model Number | 8.16.20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATA INNOVATIONS LLC |
| Manufacturer Address | 120 KIMBALL AVE SUITE 100 SOUTH BURLINGTON, VT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |