USYSTEMS INVENIA GEN 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for USYSTEMS INVENIA GEN 2 manufactured by Hcs Sunnyvale.

Event Text Entries

[39536192] Ge healthcare's investigation is ongoing. A supplemental report will be provided when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


[39536193] It was reported that a primary lesion marker for a breast ultrasound scan allegedly moved posterior unexpectedly on a subsequent reading of the study. In this particular case, the reading physician was the same physician who performed the study and therefore the issue was obvious to the user. It is unknown whether or not the reading device was manufactured by ge healthcare. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2954903-2016-00001
MDR Report Key5464394
Date Received2016-02-26
Date of Report2016-02-26
Date of Event2016-01-19
Date Mfgr Received2016-01-28
Device Manufacturer Date2014-10-23
Date Added to Maude2016-02-26
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 ContactMR JAMES GILES
Manufacturer Street3000 N GRANDVIEW BLVD
Manufacturer CityWAUKESHA WI 53188
Manufacturer CountryUS
Manufacturer Postal53188
Manufacturer Phone2625482089
Manufacturer G1HCS SUNNYVALE
Manufacturer Street447 INDIO WAY
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUSYSTEMS INVENIA GEN 2
Generic NameAUTOMATED BREAST ULTRASOUND
Product CodePAA
Date Received2016-02-26
OperatorPHYSICIAN
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHCS SUNNYVALE
Manufacturer Address447 INDIO WAY SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-26

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