MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for BIOVISION manufactured by Faxitron Bioptics, Llc.
[98454910]
Patient Sequence No: 1, Text Type: N, H10
[98454951]
Biomedical engineering department received a call that the faxitron biovision was locked up. Imaging engineer went down the or to investigate. Upon arriving the imaging engineer witness the device was locked up. The engineer went to investigate the log files and found out that someone had downloaded music and was using the systems internet service to access the music. Once the device was reset, the system was able to boot back up properly and was tested and returned to service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7224815 |
| MDR Report Key | 7224815 |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-09-15 |
| Report Date | 2018-01-17 |
| Date Reported to FDA | 2018-01-17 |
| Date Reported to Mfgr | 2018-01-17 |
| Date Added to Maude | 2018-01-29 |
| 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 |
| 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 | CABINET, X-RAY SYSTEM |
| Product Code | MWP |
| Date Received | 2018-01-29 |
| Model Number | BIOVISION |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FAXITRON BIOPTICS, LLC |
| Manufacturer Address | 3440 EAST BRITANNIE DRIVE SUITE 150 TUSCON AZ 85706 US 85706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-29 |