MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-07-11 for ASCOM MOBILE MONITORING GATEWAY (MMG) SW000400 manufactured by Ascom (sweden) Ab.
| Report Number | 3008952681-2019-00001 |
| MDR Report Key | 8783390 |
| Report Source | OTHER |
| Date Received | 2019-07-11 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-06-12 |
| Date Mfgr Received | 2019-06-12 |
| Device Manufacturer Date | 2018-03-22 |
| Date Added to Maude | 2019-07-11 |
| 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 | CHRISTOPHER WOOD |
| Manufacturer Street | 9024 TOWN CENTER PARKWAY |
| Manufacturer City | BRADENTON FL 34202 |
| Manufacturer Country | US |
| Manufacturer Postal | 34202 |
| Manufacturer Phone | 9416845497 |
| Manufacturer G1 | ASCOM (SWEDEN) AB |
| Manufacturer Street | GRIMBODALEN 2 |
| Manufacturer City | GOTEBORG, SE-41749 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-41749 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCOM |
| Generic Name | MOBILE MONITORING GATEWAY (MMG) |
| Product Code | MSX |
| Date Received | 2019-07-11 |
| Model Number | MOBILE MONITORING GATEWAY (MMG) |
| Catalog Number | SW000400 |
| Lot Number | VERSION 4.4.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCOM (SWEDEN) AB |
| Manufacturer Address | GRIMBODALEN 2 GOTEBORG, SE-41749 SW SE-41749 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-07-11 |