MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-09 for GE MEDICAL SYSTEMS VIVID 71930 H45521AC manufactured by Ge Medical Systems.
[20996365]
Software on the g. E. Vivid 7 ultrasound does not accommodate entries on same individual for multiple studies. Images and data are effectively "lost" or unable to be retrieved once 2nd stage or exam is completed. Software does not account for additional studies to same pt on different days. It will error and indicate that pt already exists. If a new exam is started, it asks if you want to save? When "all" is selected, original images/data is still there, but most recent study is not, with no indication or error notifying the technician performing the study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037666 |
| MDR Report Key | 663494 |
| Date Received | 2005-01-09 |
| Date of Report | 2005-12-01 |
| Date of Event | 2005-11-22 |
| Date Added to Maude | 2006-01-17 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE MEDICAL SYSTEMS |
| Generic Name | VIVID 7 ECHO MACHINE |
| Product Code | DXK |
| Date Received | 2006-01-09 |
| Model Number | VIVID 71930 |
| Catalog Number | H45521AC |
| Lot Number | BT02 PLUS |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 652914 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | * JACKSONVILLE FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-09 |