MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for INSTRUMENT MANAGER SOFTWARE CALCULATOR / DATA PROCESSING MODUL V8.12.01 manufactured by Data Innovations Llc.
| Report Number | MW5087331 |
| MDR Report Key | 8696502 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-05-07 |
| Date Added to Maude | 2019-06-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INSTRUMENT MANAGER SOFTWARE CALCULATOR / DATA PROCESSING MODUL |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2019-06-12 |
| Model Number | V8.12.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATA INNOVATIONS LLC |
| Manufacturer Address | SOUTH BURLINGTON VT 05403 US 05403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-06-12 |