MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for TILTING HEAD FIXATION SYSTEM (SOLSTICE) CHS04 manufactured by Medtec, Inc. D/b/a Civco Radiotherapy.
[145774289]
Risks: during patient setup, when patient moves from inferior to superior position, the patient's motion and force against the bowl may cause rotation even when device is locked. Rotation of the bowl during the setup makes the device difficult to use. Clinicians would be required to reposition the patient if movement was detected. If movement was not detected, and confirmation image was not performed, movement could result in serious patient injury due to unintended change in patient setup location. Mitigations: if a setup confirmation image is performed prior to treatment and/or surface guided radiation therapy (sgrt) is utilized during treatment movement may be detected. Movement may also be detected by clinicians through visual confirmation of indexing positions provided on the device. The ifu also provides the following warning statements: "warning: verification image should be taken to confirm patient position prior to treatment. " and "warning: ensure device is secure prior to use". Conclusion: based on the risk of unintended movement of the device and the potential for that movement to go undetected by the clinician, a field action is being conducted. Intent to recall (1932738-4/10/19-001) was reported to the fda on 4/15/2019.
Patient Sequence No: 1, Text Type: N, H10
[145774290]
User site on (b)(6) reported bowl movement noted on (b)(6) during patient setup while lock was engaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2019-00001 |
| MDR Report Key | 8519209 |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-02-20 |
| Date Added to Maude | 2019-04-16 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TILTING HEAD FIXATION SYSTEM (SOLSTICE) |
| Generic Name | SOLSTICE |
| Product Code | IXR |
| Date Received | 2019-04-16 |
| Model Number | CHS04 |
| Catalog Number | CHS04 |
| Lot Number | M789110 OR M812200 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC. D/B/A CIVCO RADIOTHERAPY |
| Manufacturer Address | 1401 8TH STREET SE ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-16 |