MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-25 for POLYDOROS * manufactured by Siemans Medical.
[2948274]
X-ray tube in fluoro room not working. Can't be moved to perform procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2814280 |
| MDR Report Key | 2814280 |
| Date Received | 2012-10-25 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-09-21 |
| Report Date | 2012-10-25 |
| Date Reported to FDA | 2012-10-25 |
| Date Added to Maude | 2012-11-01 |
| 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 |
| 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 | POLYDOROS |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPY |
| Product Code | IZO |
| Date Received | 2012-10-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMANS MEDICAL |
| Manufacturer Address | 51 VALLEY STREAM PKWY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-25 |