MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-08-05 for IBEAM P10105-101 manufactured by Medical Intelligence Medizintechnik-gmbh.
[2264597]
There has been at least four occasions where a pt has been burned during treatments. This is happening when they are completing a "pa" and "ap" treatment when the gantry is fixed and applying a dose. As a result of this condition the pt(s) had to be treated for burns by the doctor.
Patient Sequence No: 1, Text Type: D, B5
[9260352]
The device was used in combination with a varian linear accelerator and a philips adac pinnacle planning software. It appears that during planing the build-up effect of a solid material, i. E. Carbon fibre board was not considered. The build-up effect is extensively described in the instruction for use (ifu) together with a direction to consider skin-effects during planning of the treatment. The adac pinnacle seems to not automatically adjust build-up effects and the user error could not be corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710332-2011-00001 |
| MDR Report Key | 2218750 |
| Report Source | 00,07 |
| Date Received | 2011-08-05 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-06-30 |
| Date Mfgr Received | 2011-07-08 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2012-06-21 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IBEAM |
| Generic Name | PATIENT POSITIONING SYSTEM |
| Product Code | IXQ |
| Date Received | 2011-08-05 |
| Model Number | NA |
| Catalog Number | P10105-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH |
| Manufacturer Address | SCHWABMUNCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-08-05 |