MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-19 for SIMVIEW 3000 SIMULATOR 01957153 NA manufactured by Siemens Medical Solutions Usa, Inc., Radiation Oncology.
[20739581]
Siemens received a report on (b)(6) 2011, noting that when the operator moved the table down at the end of a patient's simulation session on the simview 3000 simulator, the table rapidly fell down about 50 cm with the patient on top of it. Reportedly, the patient was not injured. The patient came down from the table and went out of the room on his own. Since that time the table did not move in the vertical direction. This reported issue occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[20907673]
Siemens became aware of the reported event on (b)(4) 2011 and are mailing the mdr on (b)(4) 2012. Siemens customer service engineer found during evaluation that the main chain for the motor and the lifting screw or barring were both broken. The broken chain was replaced, and a new table base and table cable were installed. The simulator is back in use by the customer. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2012-00006 |
| MDR Report Key | 2443390 |
| Report Source | 07 |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-20 |
| Date Mfgr Received | 2011-12-20 |
| Date Added to Maude | 2012-08-08 |
| 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 Contact | MARLYNNE GALLOWAY |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102195361 |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Street | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMVIEW 3000 SIMULATOR |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2012-01-19 |
| Model Number | 01957153 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-19 |