MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-10 for CEILING MOUNTED RADIATION SHIELD UST-400R GE #NW3006AA manufactured by United Shielding.
[102150]
It was reported to ge that the red shield fell and struck the pt. Apparently, this caused trauma to the liver of the pt and damaged the table. The equipment has been taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 57583-1997-00035 |
| MDR Report Key | 125639 |
| Date Received | 1997-10-10 |
| Date of Report | 1997-10-10 |
| Date of Event | 1997-10-09 |
| Date Facility Aware | 1997-10-09 |
| Report Date | 1997-10-10 |
| Date Reported to FDA | 1997-10-10 |
| Date Reported to Mfgr | 1997-10-10 |
| Date Added to Maude | 1997-10-15 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | CEILING MOUNTED RADIATION SHIELD |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | IWQ |
| Date Received | 1997-10-10 |
| Model Number | UST-400R |
| Catalog Number | GE #NW3006AA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122986 |
| Manufacturer | UNITED SHIELDING |
| Manufacturer Address | 243 BOSTON TOPSVILLE MA 01983 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-10-10 |