3SC-RS PROBE W/VIVID IQ

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 2020-02-27 for 3SC-RS PROBE W/VIVID IQ manufactured by Ge Medical Systems (china) Co., Ltd (wuxi).

Event Text Entries

[181238196] Patient information could not be obtained due to country privacy laws. The initial reporter did not provide the date of incident. Vivid iq udi: (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Ge healthcare's investigation is ongoing. Legal manufacturer: parallel design sas (hcs nice) - (b)(4). Device evaluation anticipated, but not yet begun
Patient Sequence No: 1, Text Type: N, H10


[181238197] A customer reported that a 3sc-rs ultrasound probe, when used with a vivid iq, had interference when activating the color doppler and pw doppler. This occurred while attempting to perform a bedside echocardiographic exam at a coronary icu when the interference appeared suddenly making it impossible to perform the exam. The patient had acute dysfunction due to thrombosis of a mitral mechanical prosthesis, which was undiagnosed due to the interference, who ended up dying for lack of diagnosis hours after the failed attempt to perform the exam.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710602-2020-00071
MDR Report Key9765688
Report SourceFOREIGN,USER FACILITY
Date Received2020-02-27
Date of Report2020-02-27
Date Mfgr Received2020-01-28
Device Manufacturer Date2018-08-07
Date Added to Maude2020-02-27
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 Name3SC-RS PROBE W/VIVID IQ
Generic NameULTRASOUND IMAGING SYSTEM
Product CodeIYN
Date Received2020-02-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
Manufacturer AddressNO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE WUXI 214028 CH 214028


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-27

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