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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CADSTREAM

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MERGE HEALTHCARE MERGE CADSTREAM Back to Search Results
Model Number MERGE CADSTREAM V5.2.9.711
Device Problems Computer Software Problem (1112); Device Issue (2379)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2018
Event Type  Malfunction  
Manufacturer Narrative

The user manual and reference guide describe the limitations of cadstream, which caution diagnostic or other patient management decisions should not be based solely on the results of cadstream. Merge healthcare is attempting to obtain additional information from the customer to further investigate the allegation. For this reason, conclusion, has been selected.

 
Event Description

Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies. Cadstream supports evaluation of dynamic mr data acquired during contrast administration. Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats). On (b)(6) 2018, merge technical support was contacted by a user reporting that images in cadstream displayed the incorrect patient orientation. Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities. The customer's issue is suspected of originating at the mr scanner during the patient's scan acquisition. While there is no indication that the issue reported by the customer resulted in any harm to a patient, study results having the potential to become part of the patients permanent record and records have the potential to impact a patient's treatment; therefore there is a possibility for a misdiagnosis or mistreatment that could lead to harm. However, there is no indication of harm to a patient as a result of this issue. (b)(4).

 
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Brand NameMERGE CADSTREAM
Type of DeviceMERGE CADSTREAM
Manufacturer (Section D)
MERGE HEALTHCARE
900 walnut ridge rive
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 Key7513319
MDR Text Key108726997
Report Number2183926-2018-00039
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK092954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator RADIOLOGIC TECHNOLOGIST
Device MODEL NumberMERGE CADSTREAM V5.2.9.711
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 Received04/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/23/2010
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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