MERGE UNITY PACS UNITY PACS R11.2.5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-06-11 for MERGE UNITY PACS UNITY PACS R11.2.5 manufactured by Merge Healthcare.

MAUDE Entry Details

Report Number2183926-2019-00021
MDR Report Key8689922
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-06-11
Date of Report2019-05-13
Date of Event2019-05-13
Date Mfgr Received2019-05-13
Device Manufacturer Date2017-07-24
Date Added to Maude2019-06-11
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 ContactMEG MUCHA
Manufacturer Street900 WALNUT RIDGE DRIVE
Manufacturer CityHARTLAND WI 53029
Manufacturer CountryUS
Manufacturer Postal53029
Manufacturer G1MERGE HEALTHCARE
Manufacturer Street900 WALNUT RIDGE DRIVE
Manufacturer CityHARTLAND WI 53029
Manufacturer CountryUS
Manufacturer Postal Code53029
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERGE UNITY PACS
Generic NamePICTURE AND ARCHIVING COMMUNICATIONS SYSTEM
Product CodeLLZ
Date Received2019-06-11
Model NumberUNITY PACS R11.2.5
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 2019-06-11

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