MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-04 for SIEMENS * manufactured by Siemens Medical Systems.
[18598142]
During a left heart catheterization the fluoroscopy and cine were not functional. Pt was moved to another room with no harm resulting to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015111 |
| MDR Report Key | 200549 |
| Date Received | 1998-12-04 |
| Date of Report | 1998-11-24 |
| Date of Event | 1998-11-18 |
| Date Added to Maude | 1998-12-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS |
| Generic Name | FLUORO |
| Product Code | IZJ |
| Date Received | 1998-12-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | FIXED BY SIEMENS 11/20/1998 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 194806 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Manufacturer Address | 16 ELECTRONICS AVE. DANVERS MA 01923 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-04 |