MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-05 for ONCENTRA SIMULATION 127.001 manufactured by Nucletron Bv.
[2283715]
User detected that the display was rotated. Image frames of cbct series might be missing, causing the display to be rotated. Under normal conditions, when the rotation is clinically significant the rotation will be noticed.
Patient Sequence No: 1, Text Type: D, B5
[9307927]
In some situations the images of cbct series may be displayed with a rotation. In most situations this can be noticed very clearly, e. G. When the tabletop is included in the images. In other situations the user will be able to see this rotation as the pt will appear to have rotated especially when radiopaque pt markers or laser positioning have been used. The install date for this software is (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611894-2011-00003 |
| MDR Report Key | 2280384 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-10-04 |
| Date of Event | 2011-09-07 |
| Date Mfgr Received | 2011-09-07 |
| Date Added to Maude | 2012-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MICHAEL PAUL |
| Manufacturer Street | 7021 COLUMBIA GATEWAY DR STE 200 |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal | 21046 |
| Manufacturer Phone | 4435452182 |
| Manufacturer G1 | NUCLETRON BV |
| Manufacturer Street | WAARDGELDER 1 |
| Manufacturer City | VEENENDAAL 3905TH |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3905 TH |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONCENTRA SIMULATION |
| Generic Name | ONCENTRA SIMULATION |
| Product Code | KPQ |
| Date Received | 2011-10-05 |
| Model Number | 127.001 |
| Catalog Number | 127.001 |
| Lot Number | NA |
| ID Number | SOFTWARE V2.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON BV |
| Manufacturer Address | VEENENDAAL NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-05 |