• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM Back to Search Results
Model Number UNITY PACS 11.0.0
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
Merge unity pacs is designed to display a message to the user when an exam report fails to upload to the image server. Station logs were unavailable for review. It was not possible to determine if the error message displayed on the screen for the doctor when the report was first read and saved notified the failure to upload. There was no evidence that report was saved. The unity support technician's investigation showed that the unity pacs station crashed before the report was uploaded and saved. As a result of finalized report being unavailable, the exam was re-read by a physician. No other review/investigation will be performed for cause.
 
Event Description
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 4/13/2018, the customer reported that the report was missing for an exam (dated (b)(6) 2018) that was dictated by the doctor on (b)(6) 2018. Merge technical support investigated the customer's allegation by reviewing the merge unity pacs workstation. Technical support did identify a station crash and there was no data uploaded and therefore the report was not available. The exam was required to be re-read by the physician. The exam was re-read on (b)(6) 2018. 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. However, the customer did not allege any harm, serious injury or death as a result of this issue. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMERGE UNITY PACS
Type of DevicePICTURE AND ARCHIVING COMMUNICATIONS SYSTEM
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
MDR Report Key7509431
MDR Text Key108493533
Report Number2183926-2018-00035
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 04/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS 11.0.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-