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

Model Number 9.20

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operational Issue (2914)

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

Event Date 06/12/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.Customer reported that on the live waveform display that the ffr is showing.78 for the recording at 12:42:42am however in the recorded waveform he cannot get that value of.78 from any of the recorded beats.This was found to be due to the software design.The system is designed to calculate ffr two different ways on the client pc (for chron log recording) and on the hemomonitor for display.On the hemomonitor the system calculates ffr by taking the quotient of the average of pa and the average of pd, and displays that minimum value.In the client pc, the system takes the average of the quotient of pa and pd.If there is a difference between the value displayed on the hemomonitor and the value recorded in the chron log, and the cardiologist uses the value displayed on the hemomonitor for clinical decisions, there is a potential of over treatment or undertreatment.(b)(4).

• Brand Name: MERGE HEMO
• Type of Device: HEMODYNAMICS MONITORING AND RECORDING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53209
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53209
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53209 ; 2629123570
• MDR Report Key: 5437901
• MDR Text Key: 38227797
• Report Number: 2183926-2015-00419
• 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
• 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

• 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: 9.20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2183926-02/15/2016-065-C
• Patient Sequence Number: 1