MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-14 for SIEMENS-MAGALIX CATH PLUS 121GW BI PLANE IMAGING SYSTEM ARTIS-ZEE DBA manufactured by Siemens Fluke-v-451p.
[3198814]
(b)(6) child underwent ir procedure that resulted in an unanticipated neurologic outcome caused by equipment failure. This report was completed (b)(4) 2013 but a copy was not retained. Based on the advice from fda, a second report was done to obtain a copy for my records.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029421 |
| MDR Report Key | 3015724 |
| Date Received | 2013-03-14 |
| Date of Report | 2013-03-14 |
| Date of Event | 2001-03-06 |
| Date Added to Maude | 2013-03-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS-MAGALIX CATH PLUS 121GW BI PLANE IMAGING SYSTEM |
| Generic Name | FLUOROSCOPY |
| Product Code | IZO |
| Date Received | 2013-03-14 |
| Model Number | ARTIS-ZEE DBA |
| Lot Number | 1754 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS FLUKE-V-451P |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2013-03-14 |