MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2003-12-31 for CASE 8000 NA manufactured by Ge Medical Systems Information Technologies.
[14869022]
The acquisition module (cam-14) separated while attached to the case 8000 cardiac assessment system system for exercise testing. The ecg had to be repeated. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124823-2003-00084 |
| MDR Report Key | 507971 |
| Report Source | 00,05 |
| Date Received | 2003-12-31 |
| Date of Report | 2003-12-30 |
| Date of Event | 2003-08-01 |
| Date Mfgr Received | 2003-12-02 |
| Date Added to Maude | 2004-01-28 |
| 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 | 0 |
| Manufacturer Contact | PAUL HANNEMAN |
| Manufacturer Street | 8200 W. TOWER AVE. |
| Manufacturer City | MILWAUKEE WI 53223 |
| Manufacturer Country | US |
| Manufacturer Postal | 53223 |
| Manufacturer Phone | 4143622404 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASE 8000 |
| Generic Name | CARDIOVASCULAR ECG ANALYSIS SYSTEM |
| Product Code | LOS |
| Date Received | 2003-12-31 |
| Model Number | CASE 8000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | CAM-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 496921 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 WEST TOWER AVE. MILWAUKEE WI 53223 US |
| Baseline Brand Name | CASE 8000 CARDIAC ASSESSMENT SYSTEM FOR EXERCISE |
| Baseline Generic Name | CARDIOVASCULAR ECG ANALYSIS SYSTEM |
| Baseline Model No | CASE 8000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | CASE 8000 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K991014 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-31 |