MERGE CARDIO MERGE CARDIO V11.1.1

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 2020-02-07 for MERGE CARDIO MERGE CARDIO V11.1.1 manufactured by Merge Healthcare.

MAUDE Entry Details

Report Number2183926-2020-00003
MDR Report Key9681178
Report SourceUSER FACILITY
Date Received2020-02-07
Date of Report2020-01-15
Date of Event2020-01-15
Date Mfgr Received2020-01-15
Device Manufacturer Date2019-08-08
Date Added to Maude2020-02-07
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 021421123
Manufacturer CountryUS
Manufacturer Postal021421123
Manufacturer Phone3123540189
Manufacturer G1MERGE HEALTHCARE
Manufacturer Street900 WALNUT RIDGE DRIVE
Manufacturer CityHARTLAND WI 53029
Manufacturer CountryUS
Manufacturer Postal Code53029
Single Use3
Remedial ActionMA
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERGE CARDIO
Generic NamePICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
Product CodeLLZ
Date Received2020-02-07
Model NumberMERGE CARDIO V11.1.1
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERGE HEALTHCARE
Manufacturer Address900 WALNUT RIDGE DRIVE HARTLAND WI 53029 US 53029


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-07

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