MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-24 for MAVIG SUSSPENDED LEAD SHIELD 0T25V50 * manufactured by Siemens Medical Solutions Usa, Inc..
[393581]
Case had begun in cath lab #3 when the radiation shield and arm fell from above hitting the physician and then falling to the floor. The arm broke at the elbow joint of the arm support. It seems that the 50 pound lead shield places stress on this joint when it is moved at a certain angle. This has happened four times in the past. The manufacturer, mavig, came from germany and reinforced the supports. No patient or physician injury. Case was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 570695 |
| MDR Report Key | 570695 |
| Date Received | 2005-01-24 |
| Date of Report | 2005-01-20 |
| Date of Event | 2004-12-30 |
| Report Date | 2005-01-20 |
| Date Reported to FDA | 2005-01-24 |
| Date Added to Maude | 2005-02-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG SUSSPENDED LEAD SHIELD |
| Generic Name | RADIATION SHIELD AND ARM |
| Product Code | KPY |
| Date Received | 2005-01-24 |
| Model Number | 0T25V50 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 560543 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-24 |