MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-31 for SIEMENS BRAND NAME: SIMVIEW NT 05496992 manufactured by Siemens Medical Solutions Usa, Inc..
[16114416]
Preliminary risk assessment indicates: severity: 3 (critical) there has been no mistreatment or injury reported. However, in worst case, the shaft breaks while the image intensifier or x-ray tube is above the pt, it would run down nearly undamped and may seriously hurt the pt. Probability: c (remote). There has been no similar issue reported since introduction of simview nt and simview 3000. There is a low probability for an injury, but it may happen once. The broken shaft has been returned and sent to the material test lab for investigation. The complete motor/gearbox ((b)(4)) have been requested for investigation and will be replaced free of charge. Simview nt and simview 3000 are affected.
Patient Sequence No: 1, Text Type: N, H10
[16255609]
A potential product issue has been reported internally with the simview nt product. In the abundance of caution, this issue is being reported. The pin within the gear box on the image intensifier motor had broken. This is a problem since the image intensifier can move freely and could possible collide with the pt. No info was reported that suggests that a serious injury or mistreatment has occurred. Risk assessment is documented. Final corrective action is pending further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2910081-2010-00033 |
| MDR Report Key | 1826479 |
| Report Source | 05 |
| Date Received | 2010-08-31 |
| Date of Report | 2010-08-13 |
| Date of Event | 2010-08-10 |
| Date Mfgr Received | 2010-08-13 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2012-03-13 |
| 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 | 3 |
| 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: SIMVIEW NT |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2010-08-31 |
| Catalog Number | 05496992 |
| 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 | 2010-08-31 |