MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-07-26 for IBEAM P10105-101 manufactured by Medical Intelligence Medizintechnik-gmbh.
[17126176]
The pt was in prostate treatment and was treated with a brainlab novalis system directly with skin on the couch top. The kind of treatment was conformal beam. During the treatment, the couch top "caused that the patient got an incorrect dose treatment and has dry desquamation". Region of treatment: prostate. Applied radiation energy and modality of 6 mv. Six field technique was used and field size was roughly 6 cm x 7 cm. Delivered dose per fraction of 2 gy at 90%.
Patient Sequence No: 1, Text Type: D, B5
[17323636]
The medical intelligence couch top is like, e. G. , siemens, sinmed, and q-fix, a solid carbon fibre couch top without a tennis racket area. (b)(4). All carbon fiber tabletops result in an increase in pt skin dose and all are aware of the increase in dose. This design enables a higher stability for these couch tops and minimizes any sagging of the pt, which can occur with traditional tennis racket inserts or foil and a notably improvement imaging quality, compared to tennis racket types. Over the complete treatment area, solid carbon fiber couch tops do not have a higher dose attenuation compared to tennis racket areas. As a consequence of higher attenuation caused by the solid carbon fibre couch tops, there is a, in comparison, notably higher skin dose. Even very thin carbon fiber solid inserts, to be placed in the tennis racket area, have an notable effect on skin dose up to (b)(4) relative surface dose. Same can be noted with several state of the art immobilization devices. Corresponding (b)(4) calculations demonstrate that this effect to skin dose can be decisively compensated only by tennis rackets. Therefore, all solid carbon fibre couch tops can be stated to show similar effects. The effect has to be considered for adaption of treatment techniques. Should the user employ the same techniques, as for a couch top with tennis racket, skin reactions are more likely to occur. Opposite, couch tops with a tennis racket area have massive frame structures, which have to be considered in treatment planning as well. This imposes that couchtops may not be treated "as air".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710332-2006-00004 |
| MDR Report Key | 3068309 |
| Report Source | 08 |
| Date Received | 2006-07-26 |
| Date of Report | 2006-07-20 |
| Date of Event | 2006-06-28 |
| Date Mfgr Received | 2006-06-28 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2013-04-22 |
| 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 |
| Manufacturer Street | FEYERABENDSTRASSE 13-15 |
| Manufacturer City | SCHWABMUNCHEN 86830 |
| Manufacturer Country | GM |
| Manufacturer Postal | 86830 |
| Manufacturer Phone | 232969220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IBEAM |
| Product Code | JAI |
| Date Received | 2006-07-26 |
| Model Number | NA |
| Catalog Number | P10105-101 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH |
| Manufacturer Address | SCHWABMUNCHEN 86830 GM 86830 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-26 |