MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-16 for GE T2100 TREADMILL manufactured by Ge Healthcare.
[2713756]
Pt to have nuclear medicine cardiolite stress test. Pt was in stage 1 of bruce protocol and after 1 minute 30 seconds treadmill increased in speed without staff injecting. Tried to stop treadmill with emergency stop button. This did not work. Then hit stop treadmill on system, did not work. Pt had to jump off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025440 |
| MDR Report Key | 2583826 |
| Date Received | 2012-05-16 |
| Date of Report | 2012-05-04 |
| Date of Event | 2012-05-02 |
| Date Added to Maude | 2012-05-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE |
| Generic Name | TREADMILL |
| Product Code | IOL |
| Date Received | 2012-05-16 |
| Returned To Mfg | 2012-05-08 |
| Model Number | T2100 TREADMILL |
| ID Number | 2C24315-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 8200 W TOWER AVE MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-16 |