MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-13 for SYSTEM EQUIPMENT FLUKE V-451P manufactured by Siemens.
[3197154]
(b)(6) child underwent ir procedure that resulted in an unanticipated neurologic outcome as a result of an equipment failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029388 |
| MDR Report Key | 3010725 |
| Date Received | 2013-03-13 |
| Date of Report | 2013-03-13 |
| Date of Event | 2013-03-06 |
| Date Added to Maude | 2013-03-20 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 | SYSTEM EQUIPMENT |
| Generic Name | FLUKE V 451P SURVEY METER |
| Product Code | LHN |
| Date Received | 2013-03-13 |
| Model Number | FLUKE V-451P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-03-13 |