MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CADSTREAM; IMAGINE PROCESSING SYSTEM

Model Number MERGE CADSTREAM V6.0.1.933

Device Problem Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

This customer's allegation is being further investigated by merge healthcare.When additional information becomes available a supplemental report will be submitted.

Event Description

Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.On (b)(6) 2016 a customer reported an image exported from cadstream was showing up under a different patient in pacs.While the pacs system flagged the incoming image and alerted the customer, it is unclear at this time if the incorrect image assignment is attributed to the cadstream system or the pacs system.A patient's image showing up under a different patient has the potential of leading to a delay in care and/or an incorrect treatment or diagnosis.However, there is no indication of any harm to the patient as a result of this issue.(b)(4).

Manufacturer Narrative

Merge cadstream is prohibited from editing or modifying image dicom data received from other application entities.A review of the images in cadstream did not reveal any dicom inconsistencies between the images on the cadstream system.The issue was limited to occuring only on a 3rd party pacs product.The customer was advised and launched an investigation with the pacs manufacturer.Revised information contained in this supplemental report includes the following: g7: indication that this is follow-up report 001.H3: indication that device evaluated by manufacturer.H6: evaluation codes: method code: 10 actual device evaluated.Results code: 213 no failure detected.Conclusions code: 67 unable to confirm complaint.H10 : indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE CADSTREAM
• Type of Device: IMAGINE PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5781439
• MDR Text Key: 49131618
• Report Number: 2183926-2016-00634
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K092954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: MERGE CADSTREAM V6.0.1.933
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/10/2016
• Supplement Dates Manufacturer Received: 06/09/2016
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1