MERGE CARDIO MERGE CARDIO V10.1.2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-19 for MERGE CARDIO MERGE CARDIO V10.1.2 manufactured by Merge Healthcare.

MAUDE Entry Details

Report Number2183926-2020-00009
MDR Report Key9857238
Report SourceUSER FACILITY
Date Received2020-03-19
Date of Report2020-02-25
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Device Manufacturer Date2016-02-09
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR BRIAN BELL
Manufacturer Street75 BINNEY ST
Manufacturer CityCAMBRIDGE, MA
Manufacturer CountryUS
Manufacturer Phone3540189
Manufacturer G1MERGE HEALTHCARE
Manufacturer Street900 WALNUTRIDGE DR
Manufacturer CityHARTLAND, WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERGE CARDIO
Generic NamePICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
Product CodeLLZ
Date Received2020-03-19
Model NumberMERGE CARDIO V10.1.2
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERGE HEALTHCARE
Manufacturer Address900 WALNUT RIDGE DRIVE HARTLAND, WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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