• 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 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

  • 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 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number 6.3
Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2014
Event Type  malfunction  
Manufacturer Narrative
Submitting this supplemental report to add fda correction and removal reference numbers.
 
Manufacturer Narrative
Upon retrospective review, this issue was determined to be reportable.
 
Event Description
Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. A customer reported (case (b)(4)) that unviewed images were not displaying after the last hanging protocol step. When the user preference "show unviewed images after the last hanging protocol step" is selected, the customer expects that any images not matched to the hanging protocol will display in an auto-generated final view. However, if the last defined view of the protocol was skipped (because no images matched), the unviewed images are not displayed. This was determined to be a potential safety issue because of the risk associated with not viewing all of the images in the study.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMERGE PACS
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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 dr.
hartland, WI 53029
2629123570
MDR Report Key5437916
MDR Text Key192934001
Report Number2183926-2015-00135
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K082144
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 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6.3
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0599-2017; RES 75629

-
-