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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 8.1, 8.1.1, 8.1.2
Device Problems Computer Software Problem (1112); Application Program Problem: Parameter Calculation Error (1449)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2020
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 standalone or to integrate with vendor-neutral imaging archives (vnas) such as iconnect 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, merge healthcare received a report from a customer that hounsfield unit values reported in the 3d view were inconsistent with the hounsfield unit values reported in the 2d view of merge pacs. Upon investigation, it was discovered that pixel value measurements (including hounsfield unit measurements and suv measurements) from the probe, roi, and region analysis area tools are incorrect on multi-planar reformats (mprs) generated by merge pacs. The issue is noticeable when a modality acquires a series of images and sends the images to merge pacs. The radiologist then generates additional planes such as sagittal or coronal using mpr. Measurements done on the merge pacs generated mpr's may have incorrect measurements. Incorrect pixel measurements may result in the implementation of an incorrect or unnecessary treatment plan that could result in the patient receiving unnecessary medication, change in dosage of existing medication, or unnecessary medical procedures. 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. (b)(4).
 
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Brand NameMERGE PACS
Type of DevicePICTURE ARCHIVING COMMUNICATION SYSTEM PACS
Manufacturer (Section D)
MERGE HEALTHCARE
911 walnut ridge drive
hartland, wi
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland, wi
Manufacturer Contact
brian bell
75 binney street
cambridge, ma 
3540189
MDR Report Key10375493
MDR Text Key202053030
Report Number2183926-2020-00031
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K192455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE PACS 8.1, 8.1.1, 8.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
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
Removal/Correction NumberZ-2944-2020

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