MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-08 for GE CARDIOLAB CARDIOLAB 7000 manufactured by General Electric.
[754206]
During an svt ablation in the electrophysiology lab, the ge cardiolab system displayed "error" message on the screen. It then stopped real-time monitoring the patient. This patient was continually monitored by using the zoll defibrillator as a cardiac monitor. The ge system rebooted after three mins. The patient experienced no adverse affects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004932 |
| MDR Report Key | 978288 |
| Date Received | 2008-01-08 |
| Date of Report | 2008-01-08 |
| Date of Event | 2007-12-19 |
| Date Added to Maude | 2008-01-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 CARDIOLAB |
| Generic Name | GE CARDIOLAB SYSTEM |
| Product Code | DRR |
| Date Received | 2008-01-08 |
| Model Number | CARDIOLAB 7000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948411 |
| Manufacturer | GENERAL ELECTRIC |
| Manufacturer Address | 9900 INNOVATION DR WAUWATOSA WI 53226 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-08 |