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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 7.1
Device Problem Measurement System Incompatibility (2982)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2017
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that the suv values for 3d pet scans were not consistent with the values in the 2d images. However, the differences between the values in the 2d and 3d images were not clinically significant. The suv measurement feature has been disabled in merge pacs version 7. 1. 2. 1. There has been no allegation of direct patient impact, misdiagnosis, injury, or adverse consequences associated with the suv values being output for 3d images.
 
Event Description
Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities. On 06/13/2017 internal testing found that there were inconsistencies between the suv measurements for 2d images and suv measurements for spinning mip (maximum intensity projection). This was not reported by a customer. Reference complaint-(b)(4).
 
Manufacturer Narrative
This issue was found internally by merge healthcare staff and was not reported by a customer. Initial investigation results show that there have been no customer complaints regarding the suv measurements on for the spinning mip view. The investigation for this issue has not yet been completed. Once the investigation is completed a supplemental mdr will be filed.
 
Event Description
Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities. On (b)(6)2017 internal testing found that there were inconsistencies between the suv measurements for 2d images and suv measurements for spinning mip (maximum intensity projection). This issue was found by merge heatlhcare on (b)(6)2017 and was not reported by a customer. The issue of potentially inaccurate suv values may have an impact on patient treatments for cancer and therefore might result in harm. However, there is no indication that any patients have been negatively impacted by this issue at this time (b)(4).
 
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Brand NameMERGE PACS
Type of DevicePICTURE ARCHIVING COMMUNICATION SYSTEM PACS
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge dr
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge dr
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge dr
hartland, WI 53029
2629123514
MDR Report Key6727240
MDR Text Key249477970
Report Number2183926-2017-00154
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE PACS 7.1
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 Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2014
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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