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

Model Number MERGE HEMODYNAMICS 10.0.3

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Merge technical support provided assistance for the customer to troubleshoot the reported problem.A loose vga splitter was found, so the user reconnected it and confirmed that both hemo displays functioned correctly.Another staff member found that the vga cable was bad so replacement hardware was shipped to the customer on 10aug2016.The faulty vga cable has not yet been returned to merge healthcare for evaluation.Once the device is received and evaluated, a supplemental report will be submitted.When more information becomes available, a supplemental report will be submitted.

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) 2016, a customer reported to merge healthcare that the hemo monitor froze during a procedure and the patient was moved to another lab.With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatment that results in harm to the patient.However, the customer reported that the procedure was completed successfully once the patient was moved.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 11sep2016.As stated in the initial report, merge technical support shipped the customer a replacement video splitter/extender for a four port vga on 10aug2016.The unit was returned to merge healthcare by the customer on 09jan2017.It was found that the replacement unit was not used and confirmed that the same serial number that was shipped to the customer was the same serial number that was returned.The unit was recertified for use and returned to service stock.Merge technical support worked with the customer and found that the connections on the vga splitter were loose.Once tightened, the displays were confirmed by the customer to work correctly.To resolve the issue at the time it is recognized, the users are instructed to check the cabling and confirm that it is tight.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the general equipment care section with statements such as, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." for this reason, conclusion code 19 (human factors issue) was used.No further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious injury assessment to the patient, and the instructions provided to the user on what to do if this situation were to occur.Evaluation codes: methods code: 10 - actual device evaluated.Results code: 423 - cable.Conclusions code: 19 - human factors issue.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5942097
• MDR Text Key: 54403708
• Report Number: 2183926-2016-00718
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

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 HEMODYNAMICS 10.0.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/11/2016
• Supplement Dates Manufacturer Received: 01/09/2017
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1