• 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 PACS RADIOLOGICAL IMAGE PROCESSING 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 PACS RADIOLOGICAL IMAGE PROCESSING SYSTEM Back to Search Results
Model Number 7.0.2
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2015
Event Type  malfunction  
Manufacturer Narrative
Investigation into the root cause of the problem is underway at the time of this report.
 
Event Description
The customer believes that the standardized uptake values (suv) measurements are not as accurate when the mpr is done using a 2d image. At the time of this report, the degree of inaccuracy and its clinical significance has not been confirmed.
 
Manufacturer Narrative
An investigation into the complaint from a customer who alleged that the standardized uptake value (suv) measurements are not as accurate when the mpr is done using a 2d image, has found that the suv measurements are accurate in 2d and 3d. Evidence to support this conclusion includes the following: a merge healthcare implementation engineer contacted the customer to obtain additional information and to see if the end user would have any examples of the allegation available. A web meeting was held with an engineer at merge and a physician at the complainant's facility. The physician completed suv measurements on the same pet/ct image using three different viewers: "normal" pacs viewer, the mpr single viewer and the mpr four panel viewer. The physician found all of the suv measurements were within approximately 1/10th of each other. The physician acknowledged that these measurements were acceptable for him and his practice. To ensure that the merge pacs product functions as expected, a merge senior software developer investigated the merge pacs suv calculation related code. The developer confirmed that the code functions as intended. Additionally, when a required suv variable such as patient weight, is not available in the study, a value of "n/a" is displayed for the measurement. The investigation into this complaint also determined that merge pacs was tested according to the quantitative imaging biomarkers alliance (qiba)/ radiological society of north america (rsna) digital reference object (dro) guidance. Merge healthcare has acknowledged this report and completed the suv calculations using the dro. All test data was found acceptable. In conclusion, merge healthcare's investigation into the alleged inaccurate suv measurements were most likely due to a user error. Merge pacs satisfies the rsna/qiba guidelines for suv measurements. The customer was able to confirm after additional research and calculations using 3 different viewers, that the suv measurements were within an acceptable range. Merge healthcare's investigation confirmed that this is not a device malfunction and there was no injury, potential injury or death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMERGE PACS
Type of DeviceRADIOLOGICAL IMAGE PROCESSING 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
michael diedrick
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key5339782
MDR Text Key34885730
Report Number2183926-2015-00034
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7.0.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/24/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-