MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-10 for SIEMENS BRAND NAME: MODULEAF MLC 07334050 manufactured by Siemens Medical Solutions Usa, Inc..
[1779053]
A potential product issue has been reported with our moduleaf mlc product. In the abundance of caution this issue is being reported. The customer had a wrong leaf positioning for 8 leafs without getting any error on the cosmic control software. Only by the fact that the opposing leafs were supposed to close but could not, (as they hit already the bad leafs) the software dropped a "position not reached in time" error. On the microcontroller for moduleaf there is only one adc employed which monitors both primary and secondary pots, which is why we were not getting pot mismatch errors in the leaf positioning system. This broken adc caused the primary and secondary pot to be off by the same amount so no mismatch was detected. No information was reported that suggests a mistreatment or serious injury has occurred.
Patient Sequence No: 1, Text Type: D, B5
[8942313]
The preliminary risk assessment indicates: severity: 3 (critical). The issue may cause a mistreatment (dose to wrong location) if not recognized before irradiation is started. Probability: b (improbable). The moduleaf is used for high precision high dose treatments. It is common practice, that before treatment the setup including leaf positions are checked by using light field or imaging options. The defect also causes communication errors, which provide additional hints to the user, that something is wrong with the system. Final corrective action is pending further investigation. No other products are affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2010-00049 |
| MDR Report Key | 1944761 |
| Report Source | 07 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-11-17 |
| Date of Event | 2010-11-12 |
| Date Mfgr Received | 2010-11-17 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2011-03-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK BURGESS |
| Manufacturer Street | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9256028083 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS BRAND NAME: MODULEAF MLC |
| Generic Name | SYS, PLANNING, RADIATION THERAPY TREATMENT |
| Product Code | IXI |
| Date Received | 2010-12-10 |
| Catalog Number | 07334050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-10 |