MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-21 for ECLIPSE H48 manufactured by Varian Medical Systems.
[131379698]
Varian ref: (b)(4). This has been determined to be recurrence of complaint (b)(4). Primary root cause of the issue is missing requirement regarding the support of non-square ct images by algorithm.
Patient Sequence No: 1, Text Type: N, H10
[131379699]
Eclipse, after upgrade to 15. 6, using v13. 7. 15. User is getting range shift when inserting couch model in contouring workspace. The image, used in the plan with shifted range, contains a pixel matrix of 1090 x 684, generated in the contouring workspace when inserting a couch model - message that size is changed was acknowledged. Although the proton algorithm does not handle support structures, they always enter an appropriately shaped structure of type, none, included it in the body contour and assigned a hu that results in the same wet as the physical treatment couch. This has so far worked well in prior version v13. 7 for them. Customer was advised not to use non-square images for pcs treatment planning. Site has not reported any serious injury due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003793371-2018-00002 |
| MDR Report Key | 8189170 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-21 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-16 |
| Device Manufacturer Date | 2018-09-16 |
| Date Added to Maude | 2018-12-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. K. SEMONE |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 943041028 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041028 |
| Manufacturer Phone | 6504246833 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2916710-01-02-2019-0001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE |
| Generic Name | TREATMENT PLANNING SYSTEM |
| Product Code | MUJ |
| Date Received | 2018-12-21 |
| Model Number | H48 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 911 HANSEN WAY PALO ALTO CA 943041028 US 943041028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-21 |