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

Model Number MERGE CARDIO 10.1.1

Device Problem Device Operational Issue (2914)

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

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A merge cardio customer reported that their study list does not show new studies unless manually refreshed.The clients are getting notifications regarding report and study status updates but if they have a filter set for all qc'd reports for today and don't manually refresh the study list between reviewing studies, they don't see stat studies unless the study list is manually refreshed.(b)(4).

Manufacturer Narrative

Submitting this supplemental report to add fda correction and removal reference numbers.

• 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: 5437557
• MDR Text Key: 38228242
• Report Number: 2183926-2015-00121
• 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,Followup
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 02/15/2016
• Supplement Dates Manufacturer Received: 10/23/2015
• Supplement Dates FDA Received: 04/02/2018
• 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: Z-1486-2017; RES 76431
• Patient Sequence Number: 1