MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-21 for SIEMENS 8763724 G2142 * manufactured by Siemens.
[299327]
While radiology tech was adjusting the tube sid from 48 inches to 40 inches, the tube dropped unto the pt with full weight. (height of drop was approx 18 inches). The tube hit pt's right lower quadrant/right hip area. Abdominal and pelvis x-rays taken, pt then sent er for further follow-up and care. Field service engineer from siemens evaluation/initial assessment indicates failed spring counter weight system of the 3diii tube support. Mechanism to be removed & replaced and sent back to siemens for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 438585 |
| MDR Report Key | 438585 |
| Date Received | 2003-01-21 |
| Date of Report | 2003-01-08 |
| Date of Event | 2003-01-08 |
| Date Facility Aware | 2003-01-08 |
| Report Date | 2003-01-08 |
| Date Reported to FDA | 2003-01-08 |
| Date Reported to Mfgr | 2003-01-08 |
| Date Added to Maude | 2003-01-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SIEMENS |
| Generic Name | 3DIII OVERHEAD TUBE SUPPORT |
| Product Code | ITY |
| Date Received | 2003-01-21 |
| Returned To Mfg | 2003-01-08 |
| Model Number | 8763724 G2142 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 12 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 427505 |
| Manufacturer | SIEMENS |
| Manufacturer Address | 186 WOOD AVE SOUTH ISLIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-01-21 |