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U.S. Department of Health and Human Services

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

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MERGE HEALTHCARE MERGE UNITY PACS PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM Back to Search Results
Model Number UNITY PACS R8.2 B465
Device Problems Computer Software Problem (1112); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2018
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. 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. Merge technical support pulled the audit trail from the um on station 51 and logs for 704 on station 9. The 704 logs are truncated as of (b)(6) 2018. The audit trail was reviewed by unity technical support. The audit trail shows four events for (b)(6) 2018 with a report save event, but does not explain what happened. There is no further information available for analysis. The logs for 704 are truncated as of (b)(6) 2018 as are the automation logs. No additional information regarding the alleged report saving malfunction was available for review. The station logs had truncated, therefore were unavailable for review. Due to the lack of information for further analysis, 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 (b)(6) 2018, a customer reported that an exam was missing a report and would like assistance in retrieving it. The exam was read on (b)(6) 2018 per the customer but no report was generated. The exam was re-read on (b)(6) 2018 and a report was generated. Merge healthcare technical support pulled the audit logs that could be analyzed from related workstations for further analysis. 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. Reference complaint number (b)(4).
 
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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 Key7449387
MDR Text Key106259571
Report Number2183926-2018-00026
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 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNITY PACS R8.2 B465
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 Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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