MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-28 for SIMVIEW THERAPY SIMULATOR 05497016 manufactured by Siemens Medical Solutions Usa, Inc..
[983932]
A product issue has been reported with our simview therapy simulator. In the abundance of caution this issue is being reported. A screw fell off near image intensifier and hit a patient in the head requiring treatment of a minor injury cut above the eye. Should this failure re-occur serious injury is possible. There was an injury reported. Initial risk analysis is complete. Initial corrective action decision is pending.
Patient Sequence No: 1, Text Type: D, B5
[8160130]
Risk assessment indicates a severity: 3 (critical) personal injury of head, even if weight of related part falling down is low. Worst case: eyes could be injured. Probability: b (improbable) maintenance instructions describe that the cassette holder and its proper fixation has to be checked on a monthly basis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2009-00002 |
| MDR Report Key | 1300385 |
| Report Source | 05 |
| Date Received | 2009-01-28 |
| Date of Report | 2009-01-27 |
| Date of Event | 2009-01-09 |
| Date Mfgr Received | 2009-01-09 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2009-02-06 |
| 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 | MARK BURGESS |
| Manufacturer Street | 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMVIEW THERAPY SIMULATOR |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2009-01-28 |
| Catalog Number | 05497016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2009-01-28 |