MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-23 for INSTRUMENT MANAGER SOFTWARE V8.13.04 manufactured by Data Innovations Llc.
| Report Number | 1225673-2019-00009 |
| MDR Report Key | 8927154 |
| Date Received | 2019-08-23 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-07-26 |
| Date Mfgr Received | 2019-07-26 |
| Device Manufacturer Date | 2015-06-16 |
| Date Added to Maude | 2019-08-23 |
| 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 | MRS HEATHER HOGAN |
| Manufacturer Street | 120 KIMBALL AVENUE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON VT 05403 |
| Manufacturer Country | US |
| Manufacturer Postal | 05403 |
| Manufacturer Phone | 8022643410 |
| Manufacturer G1 | DATA INNOVATIONS LLC |
| Manufacturer Street | 120 KIMBALL AVENUE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON VT 05403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INSTRUMENT MANAGER SOFTWARE |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2019-08-23 |
| Catalog Number | V8.13.04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATA INNOVATIONS LLC |
| Manufacturer Address | 120 KIMBALL AVENUE SUITE 100 SOUTH BURLINGTON VT 05403 US 05403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-23 |