VSCAN EXTEND DUAL H41212RN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-26 for VSCAN EXTEND DUAL H41212RN manufactured by Ge Vingmed Ultrasound As.

MAUDE Entry Details

Report Number9610482-2019-00002
MDR Report Key8737525
Date Received2019-06-26
Date of Report2019-08-30
Date of Event2019-05-28
Date Mfgr Received2019-05-28
Device Manufacturer Date1970-01-01
Date Added to Maude2019-06-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOSEPH TAMBLYN
Manufacturer Street9900 W INNOVATION DR MAIL DROP: RP-2130 / B4422
Manufacturer CityWAUWATOSA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVSCAN EXTEND DUAL
Generic NameDIAGNOSTIC ULTRASOUND SYSTEM
Product CodeIYN
Date Received2019-06-26
Model NumberH41212RN
Device AvailabilityN
Device AgeDA
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 2019-06-26

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