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

Model Number MERGE CARDIO 10.1.1

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.Merge received complaint of reporting timing out and sending user back to study list which causes all reporting data being entered to be lost.This occurs if the user has the reporting open for more than an hour, the system will close the reporting and will not save the information entered.The system is designed to timeout and close the reporting after an hour of inactivity.After one hour, the service will clean up all resources of the inactive session.This results in the report not saving any of the information entered.This workflow is most common with pediatric cases and ep studies.In pediatric cases, the physicians require more than an hour for reporting due to the level of detail and research required for such reports.Ep studies typically last more than 3 hours and reporting is open for the duration of the studies.(b)(4).

• Brand Name: MERGE CARDIO
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437599
• MDR Text Key: 38219160
• Report Number: 2183926-2015-00156
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/15/2016

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: Health Professional
• Device Model Number: MERGE CARDIO 10.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-035-C
• Patient Sequence Number: 1