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

Model Number V 9.30

Device Problem Device Operational Issue (2914)

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

Event Date 12/12/2013

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.A customer reported that they were unable to equalize fractional flow reserve (ffr) during a procedure.During investigation, it was noted that there are two reasons why equalization would fail: two different channels must be chosen on the ffr setup screen, and prior to inserting wire the user must zero both channels.Customer support analyst provided the site with ffr tips for the staff in case there are questions about issue in the future after reviewing required tasks needed to equalize so than an ffr can be performed.(b)(4).

• Brand Name: MERGE HEMO
• Type of Device: HEMODYNAMICS MONITORING 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 53209 ; 2629123570
• MDR Report Key: 5437611
• MDR Text Key: 38221890
• Report Number: 2183926-2015-00208
• 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: 01/28/2016

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: Health Professional
• Device Model Number: V 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• 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