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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

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

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

The installation was completed by a 3rd party (b)(4) technician.After the installation of the replacement parts, it was noted that the 5v and 12v lights were out, thus a replacement link assembly and coil cable kit was also sent to the customer.After replacement of the hardware, the customer alleged that the issue did not resolve, the hemo monitor was still freezing (occurred four times) even after replacing the coil cable, gender changer, mounting bracket, and link assembly.A hemo pc was then sent to the customer for installation.After installation of the hemo pc, the customer reported that no further freezing events were experienced.The faulty spare link assembly was returned to merge healthcare for evaluation.The results showed a hardware error.It was determined that the serial communication port standoffs had extra washers installed, which made them too long to fully seat the connection.The standoffs were properly replaced, and passed all tests.The unit was then sent to service stock.The faulty hemo pc is to be sent back for evaluation, however, have not yet been received.Therefore, the results of the investigation are incomplete.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.The customer reported to merge healthcare that on (b)(6) 2017, while a patient went into ventricular fibrillation, the hemo screen went blank and the hemo pc had to be rebooted to function properly again.The customer reported that this was an ongoing issue.However, was not able to provide information regarding dates and outcomes of these events.No further information was provided by the customer.Trouble shooting efforts found that the thumb screws were broken off into the nuts where the coil cable plugs into the link assembly.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.(b)(4).

Manufacturer Narrative

The hemo pc was received by merge healthcare on 19jun2017.The results of the hardware evaluation found a hardware failure.The hard drive did not pass diagnostics.The hard drive was replaced and new software was reloaded onto the hemo pc.Per hemo-6373, v10 user manual: record station (page 42).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 is displayed and monitored on the hemo monitor pc.Data on third-party monitors is displayed but not manipulated by the application.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.

• 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: 6692153
• MDR Text Key: 79267709
• Report Number: 2183926-2017-00143
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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: 06/20/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1