MAUDE Adverse Event Report: MERGE HEALTHCARE RADSUITE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number RADSUITE V8.30.7.9 P1

Device Problem Image Resolution Poor (1306)

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

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

Initial investigation findings determined that the site was utilizing new storage and optimal image/data compression rules were not being applied when the study was transferred to the archive.The storage rules have been resolved.Merge healthcare is continuing to investigate the customer's allegation to determine if any additional corrections or corrective actions are required.This is not hardware.

Event Description

The merge radsuite 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.A customer reported to merge healthcare support on (b)(6) 2017 that there were "bad images pink/gren/yellow/red" for an ultrasound image that was being viewed from the archive.The customer site has not reported any patient safety concerns or delays, however if the images are blurry or are not considered to be diagnostic quality, there is a potential for patient harm, delay in treatment or diagnosis.(b)(4).

Manufacturer Narrative

Mdr 2183926-2017-00028-s1 (complaint-(b)(4).) this supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted (b)(6) 2017.During troubleshooting efforts between the customer and merge technical support, it was determined that the site has not reported any delays in treatment or diagnosis or harm to the patient, however if the images are blurry, there is a potential for patient harm, delay in treatment or diagnosis.Per support, if the images come to the ea with rle compression, configure rules to keep them rle.If the images come to the ea without compression, do not rle compress them.For the current rule, the customer likely needs to change the setting so that it does not apply to native syntaxes.If the image comes to the ea native and is stored jpeg2k lossless and is blurry, support requested that the customer please update, attach examples, logs and apply a rule to keep those uncompressed and attach logs so they can be compared.

• Brand Name: RADSUITE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6302026
• MDR Text Key: 66553502
• Report Number: 2183926-2017-00028
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K05328124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RADSUITE V8.30.7.9 P1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1