VIVID E95

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-19 for VIVID E95 manufactured by Ge Vingmed Ultrasound As.

MAUDE Entry Details

Report Number9610482-2020-00002
MDR Report Key9727507
Report SourceFOREIGN,USER FACILITY
Date Received2020-02-19
Date of Report2020-02-19
Date of Event2020-01-20
Date Mfgr Received2020-01-21
Device Manufacturer Date2019-12-09
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactJOSEPH TAMBLYN
Manufacturer Street9900 W INNOVATION DR MAIL DROP: RP-B4422
Manufacturer CityWAUWATOSA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIVID E95
Generic NameSYSTEM, IMAGING, ULTRASOUND
Product CodeIYN
Date Received2020-02-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGE VINGMED ULTRASOUND AS
Manufacturer AddressSTRANDPROMENADEN 45 HORTEN N-3191 NO N-3191


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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