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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

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MERGE HEALTHCARE MERGE PACS PICTURE ARCHIVING COMMUNICATION SYSTEM PACS Back to Search Results
Model Number MERGE PACS
Device Problem Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2020
Event Type  malfunction  
Event Description
Merge pacs is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge pacs processes and displays medical images from dicom-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage. Merge pacs software runs on off-the-shelf computer hardware and can be configured to operate stand alone or to integrate with vendor-neutral imaging archives (vnas) such as i connect enterprise archive (icea) for image storage, and with radiological and hospital information systems (ris and his) and medical record systems (emr, ehr, etc. ). On (b)(6) 2020, the customer reported that a study came in and the ct tech manually changed from unverified to unread and set the custom status to er. It updated everything as expected and showed on the radiologst's er worklist. A little later, the ct tech sent in scanned paperwork, which reverted the status back to unverified, thereby, removing the study from the radiologist's er worklist (which is expected behavior). However, the status of the study did not update to unverified on the ct tech's worklist as expected. The ct tech called the radiologist inquiring about the study and the radiologist did not have that study on their worklist. The ct tech then found that the study needed to be re-verified, thereby placing onto the radiologist's er worklist. The ct tech was not alerted that the study had been placed back in the unverified status and needed to be re-verified to unread. Based on this, there is a potential for delay in treatment that could cause harm to the patient. There have been no reports of patient injury or harm as a result of this issue.
 
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Brand NameMERGE PACS
Type of DevicePICTURE ARCHIVING COMMUNICATION SYSTEM PACS
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge drive
hartland, wi
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland, wi
Manufacturer Contact
brian bell
75 binney st
cambridge
ma 
3540189
MDR Report Key10057595
MDR Text Key194995535
Report Number2183926-2020-00020
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE PACS
Device Catalogue Number6.6.3.2
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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