MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-26 for SOARIAN manufactured by Siemens.
[1397632]
Radiology tests were ordered for eval of cough and respiratory complications. Several were completed and results were available. Two days after the orders were entered, order reconciliation was carried out. It was determined that one radiographic exam was not completed. Interface failures and/or obfuscation by inferior usability of the devices cause widespread distrust for the system of care directed by these products. Tests are not completed and it is tedious to determine what was done and what was not done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016134 |
| MDR Report Key | 1702887 |
| Date Received | 2010-05-26 |
| Date of Report | 2010-05-26 |
| Date of Event | 2010-05-16 |
| Date Added to Maude | 2010-06-03 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOARIAN |
| Generic Name | ELECTRONIC ORDERING SYSTEM |
| Product Code | LMD |
| Date Received | 2010-05-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-26 |