MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-30 for PICOM PICOM NDSCOP 2.3.5.8 manufactured by Scimage Inc..
[4219104]
Delay in care due to bug in scimage teleradiology software, which prevented timely transmission of multiple stat radiology exams. Application is erroneously rejecting associations from the facility pacs due to a license file issue. Bug has been reported to manufacturer multiple times without resolution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033669 |
| MDR Report Key | 3553997 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-12-27 |
| Date of Event | 2013-12-26 |
| Date Added to Maude | 2014-01-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PICOM |
| Generic Name | PACS |
| Product Code | LMD |
| Date Received | 2013-12-30 |
| Model Number | PICOM NDSCOP 2.3.5.8 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCIMAGE INC. |
| Manufacturer Address | LOS ALTOS CA 94022 US 94022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-30 |