MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-22 for SIEMENS ANTARES manufactured by Siemens.
[614054]
Siemens medical systems antares ultrasound system has a know software bug that siemens has been made aware of yet has taken no definitive steps to correct. The antares system is designed to purge pt study info within 24 hours of the end of the study making the info unavailable for others to view and clearing memory within the system. Instead, the studies are saved continuously until the operators become confused as to the correct study placing patients at risk. Siemens acknowledges the issue and charges customers to correct the issue each time it occurs, but said they cannot fix the issue at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5001955 |
| MDR Report Key | 856291 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-05-22 |
| Date of Event | 2007-05-22 |
| Date Added to Maude | 2007-06-07 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | SIEMENS |
| Generic Name | ANTARES ULTRASOUND |
| Product Code | BZQ |
| Date Received | 2007-05-22 |
| Model Number | ANTARES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 842097 |
| Manufacturer | SIEMENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-05-22 |