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 |