MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL manufactured by Sst Group, Inc..
[175415471]
Disk burners do not work in a timely matter. Radiology was not given enough notification from the ed to get a disk made for the patient being transferred out to another hospital. There was down time for days, so no images could be pushed. While troubleshooting the disk burners, the patient left the hospital without any images. This could result in a patient needed to be re-imaged again at the next hospital and charged again for the same exams all because communication could not be given in a more appropriate amount of time. From the systems analyst: the issue is with the group policy that the hospital applies to the computer. It disconnects the burner drives from the computer when group policy is updated. Currently we have information technology and group policy staff working on a solution. We have "experimented" with several fixes without resolution. Sst group has been contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9601275 |
| MDR Report Key | 9601275 |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-16 |
| Report Date | 2019-12-31 |
| Date Reported to FDA | 2019-12-31 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Added to Maude | 2020-01-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2020-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SST GROUP, INC. |
| Manufacturer Address | 309 LAURELWOOD ROAD SUITE 20 SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |