MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-21 for MULTIX TOP 475517 NA manufactured by Siemens Medical Solutions Usa, Inc..
[21729886]
It was reported that a male pt was sitting on a stool at the end of the multix top system table with his legs under the table. The technologist did not realize that the pt's legs were under the x-ray table and initiated downward movement of the table. The pt's legs were caught under the table for a few seconds before the operator stopped the downward movement and raised the table. The pt complained of thigh and knee pain. The x-ray images were taken at another facility but no injuries were identified. The pt was released but due to pain he is now receiving physical therapy.
Patient Sequence No: 1, Text Type: D, B5
[21885967]
The operator manual for multix top system (axb1-150. 620. 01. 01. 02) contains warnings regarding collision/crushing zones. This report was submitted october 17, 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2013-08895 |
| MDR Report Key | 3429600 |
| Report Source | 07 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-10-01 |
| Date of Event | 2013-09-05 |
| Date Mfgr Received | 2013-10-01 |
| Date Added to Maude | 2013-11-25 |
| 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 | ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY MS D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX TOP |
| Generic Name | IRADIOLOGIC TABLE |
| Product Code | IZZ |
| Date Received | 2013-10-21 |
| Model Number | 475517 |
| 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. |
| Manufacturer Address | 51 VALLEY STREAM PKWY. MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-21 |