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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Communication or Transmission Problem (2896); Noise, Audible (3273)

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

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting efforts between the customer and merge technical support confirmed that the green led lights for 5/12 v were both lit on the link assembly.It was also confirmed that all cabling was correctly connected.Merge technical support then advised the customer to reboot the hemo system.The customer was shipped replacement hardware (pdm) on 26jan2018 ((b)(4)).The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 06feb2018.The manufacturer's evaluation results found that the customer's reported problem, unit buzzing, could not be duplicated.However, the pump was found to be worn and subsequently replaced.A review of the customer's hemo case management within merge healthcare's internal database found that no other calls have been placed by the customer for this issue.Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section by statements such as, "problem - an application (the hemodynamics application or an external application) is frozen.Resolution - press ctrl+alt+delete and click task manager.Find application in the applications list and click end task.It may take several seconds for the task to be stopped.Restart application to resume." (b)(4)., communication or transmission issue (issue associated with the device sending or receiving signals or data.This includes transmission among internal components of the device and other external devices to which the device is intended to communicate.) actual device evaluated.Results - wear problem (device problems due to the premature or expected erosion of its material by use, deterioration, or change).Conclusions - device difficult to operate.

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) 2018, a customer reported to merge healthcare that the pdm (patient data module) was buzzing and the waveform display (hemo monitor) froze.Information obtained from the customer revealed that this issue has occurred several times - some incidents occurred at the end of procedures, the patient data was not affected, and the procedures were completed successfully.During another incident the issue occurred prior to starting the procedure.The patient was moved to a known working lab and the procedure was completed successfully.However, during another incident the issue occurred during the procedure and subsequently the patient was moved to a known working lab after sedation and active monitoring had been initiated.It was reported that the procedure was completed successfully.Information also obtained from the customer found that the issue has been ongoing in this lab.Even though the site has multiple labs available for use, it was the customer's choice to continue to perform procedures in this lab.Exact dates were unknown to the customer, so the customer's call in date, (b)(6) 2018, has been reflected, date of event.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 known working lab.(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: 7295010
• MDR Text Key: 101026418
• Report Number: 2183926-2018-00015
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• 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: 02/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• 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