MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-23 for * OT25U50 N/A manufactured by Siemens Medical Solutions Usa, Inc..
[338613]
During an angiography procedure the radiology technician was repositioning the lead shield suspended from the ceiling on an articulated arm. While the shield was being moved, the arm in close proximity to the ceiling mount snapped. The falling structure lacerated the technician's head. Examination of the arm revealed that the metal alloy failed creating the separation from the mount.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 549985 |
| MDR Report Key | 549985 |
| Date Received | 2003-12-23 |
| Date of Report | 2003-12-23 |
| Date of Event | 2003-12-20 |
| Report Date | 2003-12-23 |
| Date Reported to FDA | 2003-12-23 |
| Date Added to Maude | 2004-10-21 |
| 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 | 3 |
| 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 | * |
| Generic Name | SUSPENDED LEAD SHIELD |
| Product Code | KPY |
| Date Received | 2003-12-23 |
| Model Number | OT25U50 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 539504 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-23 |