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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts, merge technical support found that the windows update that the site's it department pushed out corrupted the model database.Merge technical support then overwrote the model database from a working system and then restarted sql (structured query language).It was confirmed that the client pc functioned as intended.A review of the customer's hemo case management within merge healthcare's internal database on 06oct2017 found that there have been no further call-ins by the customer regarding this issue.Device labeling, (b)(4) cardiology product security recommendations fact sheet, addresses the potential for such an occurrence with statements such as, "merge healthcare recommends that the windows firewall service be disabled on the merge hemo server, cath lab clients, and ancillary workstations.The windows firewall has caused communication problems and poor performance between the merge hemo server and connected workstations." for this reason, conclusions code 19 (human factors issue) was used.(b)(4).Methods code: actual device evaluated.Results code: interoperability problem (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components.) conclusions code: human factors issue.

Event Description

Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics 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 merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2017, a customer reported to merge healthcare that the client pc hemo application shutdown during a procedure and would not allow the medical staff to log back in with domain or local accounts.Subsequently, the patient was moved to a known working lab onsite after active monitoring had been started.The customer further stated that the site had been running software updates prior to the shutdown.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the procedure was completed successfully once the patient was moved to a functioning lab onsite.Reference complaint-(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• 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: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 6943196
• MDR Text Key: 90311987
• Report Number: 2183926-2017-00184
• 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: Other
• Type of Report: Initial
• Report Date: 09/14/2017

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 HEMODYNAMICS 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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