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

Model Number 9.30

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 08/27/2015

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 top row icons on the hemomonitor were grayed out which prevented the user from recording vitals.After further investigation it was determine that the hemomonitor pc was not communicating with client pc.The solution was to reboot the hemomonitor which interrupts vital monitoring.This case did specify if there was a patient present at the time of the event and the reboot of the hemomonitor resulted in temporary loss of vital monitor which could introduce a delay in patient care.(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: 5437939
• MDR Text Key: 38221003
• Report Number: 2183926-2015-00417
• 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: 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2183926-02/15/2016-041-C
• Patient Sequence Number: 1