MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-02 for TELEMETRY MONITORING EQUIPMENT AND SOFTWARE * manufactured by General Electric Medical Systems.
[310209]
The pt went into bradycardia and heart rate was less than 50, the telemetry beeper did not alert the run to the pt distress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 513624 |
| MDR Report Key | 513624 |
| Date Received | 2004-03-02 |
| Date of Report | 2003-12-01 |
| Date of Event | 2003-12-01 |
| Date Added to Maude | 2004-03-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELEMETRY MONITORING EQUIPMENT AND SOFTWARE |
| Generic Name | TELEMETRY MONITORING EQUIPMENT |
| Product Code | GYE |
| Date Received | 2004-03-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 502632 |
| Manufacturer | GENERAL ELECTRIC MEDICAL SYSTEMS |
| Manufacturer Address | 8200 WEST TOWER AVE MILWAUKEE WI 53223 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-03-02 |