MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO; HEMODYNAMICS RECORDING SYSTEM

Model Number 9.40

Device Problem Device Operational Issue (2914)

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

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer complaint was received in regards to the clone mode is being lost on the dell t3610's for the large screen monitors that are being connected during start up, when this happens in the field it is difficult to set this up as screen resolution is only available as a selection from the operating system when we are not connected through remote desktop protocol (rdp).The system starts up but the monitors show a black screen.Sites that choose to connect to a 3rd party monitor in the cath lab and a merge provided monitor in the control room may experience this issue.With this hardware configuration, the system is set up in clone mode to display the same "images" on both monitors.This hardware configuration along with the operating system may result in loss of clone mode.(b)(4).

• Brand Name: MERGE HEMO
• Type of Device: HEMODYNAMICS RECORDING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437598
• MDR Text Key: 38228100
• Report Number: 2183926-2015-00155
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 9.40
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1