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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CADSTREAM IMAGING PROCESSING SYSTEM

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MERGE HEALTHCARE MERGE CADSTREAM IMAGING PROCESSING SYSTEM Back to Search Results
Model Number 6.2.2.1184
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
The issue, incorrect patient orientation on all study images, was caused by incorrect data entry at the mr scanner. This is not an issue or malfunction that was caused or contributed to by the merge cadstream medical device. Cause due to an error by a technician at the scanner. No known impact to patient. No further actions are anticipated at this time.
 
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) 2020, merge technical support was contacted by a user at a facility for assistance with correcting a study with incorrect patient orientation. The patient's orientation was entered at the scanner incorrectly. Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities. Study results have the potential to become part of the patient's 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. There is no indication that this issue as reported by the customer has resulted in any harm to a patient. (b)(4).
 
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Brand NameMERGE CADSTREAM
Type of DeviceIMAGING PROCESSING SYSTEM
Manufacturer (Section D)
MERGE HEALTHCARE
75 binney st
cambridge, ma
Manufacturer (Section G)
MERGE HEALTHCARE
75 binney st
cambridge, ma
Manufacturer Contact
brian bell
75 binney st
cambridge, ma 
3540189
MDR Report Key9729522
MDR Text Key190811555
Report Number2183926-2020-00004
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6.2.2.1184
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2018
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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