• 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, AN IBM COMPANY RADSUITE IMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ

  • 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, AN IBM COMPANY RADSUITE IMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ Back to Search Results
Model Number RADSUITE V8.30.7.9
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Loss of Data (2903); Output Problem (3005); Patient Data Problem (3197); Missing Test Results (3267)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2016
Event Type  malfunction  
Manufacturer Narrative
The customer's allegation is under investigation by merge healthcare. When additional information becomes available, a supplemental report will be filed.
 
Event Description
Merge (b)(4) application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2d and reconstructed 3d radiological images using web-enabled viewers over both local and wide area networks. On 23 june 2016, merge healthcare support received a customer allegation indicating stating that "following database integrity check, exams still missing. " with exams not being available as expected, there is a potential for a delay in treatment or diagnosis which may lead to harm for a patient. There have been no reports of delay in treatment or diagnosis to a patient, harm or potential harm to a patient as a result of this issue. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRADSUITE
Type of DeviceIMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ
Manufacturer (Section D)
MERGE HEALTHCARE, AN IBM COMPANY
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key5818401
MDR Text Key51126355
Report Number2183926-2016-00661
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053281
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 06/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberRADSUITE V8.30.7.9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-