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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

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

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

Replacement hardware (link assembly, rma #(b)(4)) was shipped to the customer on (b)(6) 2018.However, the faulty unit has not been received from the customer as of (b)(6) 2018.For this reason, conclusions code (conclusion not yet available) was used.When the hardware is received and the evaluation results are available, a supplemental report will be submitted.(b)(4).Conclusions code: conclusion not yet available.

Event Description

Merge hemodynamics displays, 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) 2018, a customer reported to merge healthcare that cardiac output did not display during a procedure.The customer further reported that a patient was moved to another onsite lab after sedation and active monitoring had been initiated.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.Reference complaint-(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 08sep2018.Merge technical support assisted the customer with testing the pdm (patient data module) with the provided test plug/simulator.An error message, "no co module," was displayed so merge technical support shipped a v2 4p link assembly to the customer on 10aug2016.The faulty unit was returned by the customer on 26sep2016 for evaluation.The unit was tested according to hemo-5927 (hemo patient data monitor build and test procedure) and it passed.Therefore, the customer's reported problem could not be confirmed as there were no issues with cardiac output temperatures nor analog outputs.All values were within normal range.Upon receipt of the replacement hardware, the customer confirmed that the issue was resolved and the affected lab was fully operational.A review of the customer's hemo case management within merge healthcare's internal database found that there have been no other reports of this issue as of 10oct2018.Device labeling, hemo-5303 v9 user manual, addresses the potential for such an occurrence in the system diagnostics section which states, "simulator usage: a simulator has been included as a service tool for troubleshooting problems with ecg waveforms.A field engineer can easily connect the simulator to bring up test ecg waveforms to determine if the problem is with the ecg cables or the pdm.Test with a known good set of ecg cables.Connect ecg leads to simulator.Go to settings.Turn off all filters.See the square wave on the hemo monitor.If any the square waves are missing, there's a cable problem.If a 12 lead set is being used, try each v- lead one at a time on the v post." no further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to the patient, and the instructions provided to the user on what to do if this situation were to occur.Date new information received by manufacturer (rma closure date - 28sep2018).Indication of additional manufacturer information and corrected data are contained in this follow-up report.

• 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: 7858651
• MDR Text Key: 119651031
• Report Number: 2183926-2018-00083
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1