MERGE UNITY PACS MERGE UNITY PACS R11.0.5

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 2019-05-02 for MERGE UNITY PACS MERGE UNITY PACS R11.0.5 manufactured by Merge Healthcare.

Event Text Entries

[145617378] Merge unity pacs is designed to display a message to the user when an exam report fails to upload to the image server. In this instance, there was no evidence that the physician received the message warning that the report did not upload. It was not possible to determine if the message displayed on the screen for the physician when the report was first read and saved. Troubleshooting from unity support found that there was a reported generated, however the document was not associated correctly to the exam. The exam was generated again by the site and the they confirmed that the exam was able to be re-read without incident. No further action required at this time.
Patient Sequence No: 1, Text Type: N, H10


[145617379] Merge unity pacs is a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. On (b)(6) 2019 the customer reported an exam was marked read, however, there is no exam report. The report was saved, but not associated properly with the exam. A cause of the failed association was not able to be determined. An investigation showed the report did not upload successfully and had to be read again by the doctor. There was no reported adverse event to the patient. However, while images are available, a finalized report not being available for subsequent review by the patient's physician could potentially result in a delay in care that could lead to harm. Reference complaint-(b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183926-2019-00018
MDR Report Key8573112
Report SourceUSER FACILITY
Date Received2019-05-02
Date of Report2019-04-04
Date of Event2019-04-04
Date Mfgr Received2019-04-04
Device Manufacturer Date2017-07-26
Date Added to Maude2019-05-02
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 ContactMS. MEG 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 Received2019-05-02
Model NumberMERGE UNITY PACS R11.0.5
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMERGE HEALTHCARE
Manufacturer Address900 WALNUT RIDGE DRIVE HARTLAND WI 53029 US 53029


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-02

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