MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for SOARIAN manufactured by Siemens.
[4921692]
The mdds display of laboratory data is misleading because the date at the top of the column does not apply to all lab data below in the same general column. Thus, there may be data, for instance a low hemoglobin level, that was obtained one year ago, that appears in the same column as yesterday's result. This leads to errors and dangerous decisions, because they are based on data that is not current but may be thought to be current. Devices with such misleading formats should be recalled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038292 |
| MDR Report Key | 4114532 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-05-23 |
| Date Added to Maude | 2014-09-25 |
| 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 | MDDS/EHR |
| Product Code | NSX |
| Date Received | 2014-09-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN 19355 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2014-09-16 |