MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-26 for INTELLISPHERE EVENT MANAGEMENT 866030 manufactured by Philips Medical Systems.
| Report Number | 1218950-2019-07383 |
| MDR Report Key | 9125090 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-26 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2016-11-21 |
| Date Added to Maude | 2019-09-26 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLISPHERE EVENT MANAGEMENT |
| Generic Name | COMMUNICATION SYSTEM |
| Product Code | MSX |
| Date Received | 2019-09-26 |
| Model Number | 866030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-09-26 |