MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for MONARCH MODEL 1000 ACS - WIFI PMACS1WI manufactured by Hill-rom Singapore.
| Report Number | 3008145987-2019-00002 |
| MDR Report Key | 9143463 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-08-28 |
| Date Mfgr Received | 2019-09-05 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2019-10-01 |
| 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 | LORI DAULTON |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONARCH MODEL 1000 ACS - WIFI |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2019-10-01 |
| Model Number | PMACS1WI |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-01 |