MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-15 for CASE T2000/CASE P2 SERIES ECG 500010616 manufactured by Ge Medical Systems Information Technologies.
| Report Number | 3417755 |
| MDR Report Key | 3417755 |
| Date Received | 2013-07-15 |
| Date of Report | 2013-07-15 |
| Date of Event | 2013-07-03 |
| Report Date | 2013-07-15 |
| Date Reported to FDA | 2013-07-15 |
| Date Reported to Mfgr | 2013-10-18 |
| Date Added to Maude | 2013-10-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASE |
| Generic Name | EXERCISER |
| Product Code | IOL |
| Date Received | 2013-07-15 |
| Model Number | T2000/CASE P2 SERIES ECG |
| Catalog Number | 500010616 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 W TOWER AVE MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-15 |