MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for FDR D-EVO SUITE II DR-ID600 N/A manufactured by Fujifilm Corporation.
[144755979]
During a service call for an issue related to image artifacts, fujifilm medical systems usa (fmsu) was informed that a patient was re-imaged three (3) additional times; the anatomy being radiated was the sacrum coccyx. The customer informed fmsu that the technique values were entered manually by the radiology technician and were not verified prior to exposing the patient. The technique values were 80 kvp / 271 mas and 80 kvp / 258 mas and sid 40cm. The re-exposures were performed in a room equipped with a d-evo suite comprised of devo panel, console, table and x-ray tube and generator. The customer mentioned that there were no signs of serious injuries associated as a result of the re-exposures. After the two exposures were performed the customer sent the patient to another location to finish the exam. This event is being reported in an abundance of caution due to the exposure dose and age of the patient. There was no patient death or serious injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000513161-2019-00003 |
| MDR Report Key | 8601210 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-03-08 |
| Date Facility Aware | 2019-04-15 |
| Report Date | 2019-05-10 |
| Date Reported to FDA | 2019-05-10 |
| Date Reported to Mfgr | 2019-05-09 |
| Date Added to Maude | 2019-05-10 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Brand Name | FDR D-EVO SUITE II |
| Generic Name | FLAT PANEL DIGITAL DETERCTOR, |
| Product Code | MQB |
| Date Received | 2019-05-10 |
| Model Number | DR-ID600 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM CORPORATION |
| Manufacturer Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 002588538 JA 002588538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |