MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-06 for G.E. PRESTILIX 1600S 827.300 6015 manufactured by G.e. Medical Systems.
[18732]
A spot film of c-7 was needed. The table bucky was placed in the upright 90 degree position. The pt was then seated inbetween the table and the x-ray tube in a left lateral position. The tech used the joystick from the remote operated consol to move the tube downward, the arm of the tube struck the pt's left knee. As a result the pt's heel hit the floor causing a fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32733 |
| MDR Report Key | 32733 |
| Date Received | 1995-07-06 |
| Date of Report | 1995-01-16 |
| Date of Event | 1995-01-06 |
| Date Facility Aware | 1995-01-06 |
| Report Date | 1995-01-16 |
| Date Reported to Mfgr | 1995-01-16 |
| Date Added to Maude | 1996-05-09 |
| 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 | G.E. PRESTILIX 1600S |
| Generic Name | RADIOGRAPHIC MACHINE |
| Product Code | ITY |
| Date Received | 1995-07-06 |
| Model Number | 827.300 6015 |
| Operator | OTHER |
| Device Availability | * |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34013 |
| Manufacturer | G.E. MEDICAL SYSTEMS |
| Manufacturer Address | 20 WATERVIEW BLVD PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-06 |