MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number MERGE HEMO V9.40.1

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

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

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

Based upon the available information, the cause for the reported event was due to the customer not following instructions concerning the installation of anti-virus software; therefore, there is no indication that the reported event was related to product malfunction or defect.The product security recommendations, (b)(4), explicitly state, "the intent of these guidelines is to configure the anti-virus software so that it does not affect clinical performance and uptime while still being effective.To accomplish this, the anti-virus software needs to be configured to scan only the potentially vulnerable files on the system, while skipping the medical images and patient data files.Our experience has shown that improper configuration of anti-virus software can have adverse affects including downtime and clinically unusable performance.".

Event Description

Merge hemo monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the hemo monitor pc via the serial interface.All data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that, in the middle of a heart catheterization procedure, the hemo monitor pc lost communication with the hemo client and the hemo monitor went black.Information obtained from the customer indicated that there was a delay of about 5 minutes while the patient was sedated so that the application could be rebooted.It was found that anti-malware software was performing hourly scans.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, it was reported that the procedure was completed successfully once the application was rebooted.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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: 5487204
• MDR Text Key: 39935444
• Report Number: 2183926-2016-00479
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

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 HEMO V9.40.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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