MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-04 for 2000 SYSTEM 087-815264 * manufactured by Burkhart Roentgen Intl.
[30447]
Lead shield broke from its support mounted from the ceiling and fell towards the floor. The operator of the shield was holding it when it broke away from the support. The pt was not injured. Per mfr protective shield fell-weld broke. Upon inspection of the returned window frame, it was discovered that there was damage to the welded pivot from some previous impact. A safety cable was installed inside the pivot and the pivot was re-welded and re-enforced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 48797 |
| MDR Report Key | 48797 |
| Date Received | 1996-10-04 |
| Date of Report | 1996-10-04 |
| Date of Event | 1996-09-26 |
| Date Facility Aware | 1996-09-26 |
| Report Date | 1996-10-04 |
| Date Reported to Mfgr | 1996-09-26 |
| Date Added to Maude | 1996-11-15 |
| 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 | 2000 SYSTEM |
| Generic Name | PROTECTION SHIELD |
| Product Code | IWQ |
| Date Received | 1996-10-04 |
| Returned To Mfg | 1996-10-01 |
| Model Number | 087-815264 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 49556 |
| Manufacturer | BURKHART ROENTGEN INTL |
| Manufacturer Address | 6571 43RD ST, NORTH STE 1704 PINELLAS PK FL 34665 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-04 |