MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-21 for GE MEDICAL GE VIVID 7 H45521AC manufactured by Ge Medical.
[508780]
Tee echo study done and transmitted from machine. Lost from hard drive including all alpha and numerical data.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036680 |
| MDR Report Key | 746531 |
| Date Received | 2005-09-21 |
| Date of Report | 2005-08-23 |
| Date of Event | 2005-08-19 |
| Date Added to Maude | 2006-08-14 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE MEDICAL |
| Generic Name | VIVID 7 ECHO PAC |
| Product Code | DXK |
| Date Received | 2005-09-21 |
| Model Number | GE VIVID 7 |
| Catalog Number | H45521AC |
| Lot Number | BT 02 PLUS |
| ID Number | PIN FC 000210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 734329 |
| Manufacturer | GE MEDICAL |
| Manufacturer Address | * JACKSONVILLE FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-21 |