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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Device Issue (2379); Device Operational Issue (2914)

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

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that they were able to get the hemo monitor working again and completed the case successfully.Although the customer was able to get the hemo monitor functioning again, a cause for the customer's allegation have not been determined.For this reason, conclusions code (conclusion not yet available-evaluation in progress) was used.A supplemental report will be submitted when all the information is available.

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, during a case, while the patient was already sedated and being actively monitored, the client pc's mouse stopped working.After a reboot of both the hemo monitor pc and client pc, the mouse began working again but the hemo monitor would not display correctly.There was a two minute delay while rebooting both the client pc and hemo monitor pc, however, no alternative monitoring equipment was used.With merge hemo not capturing physiological data, the device is not working as expected, therefore, could cause harm to the patient.The customer was able to get the hemo pcs and monitors working as expected and the procedure was completed successfully.Reference complaint number: (b)(4).

Manufacturer Narrative

Further information was received from hemo support that the monitor's input source was set correctly.After the hemo pc was rebooted, the cable splitter was not receiving power during troubleshooting.Once power was provided to the cable splitter, the issue was resolved.Per hemo-6373 merge hemo 10 user manual equipment care (p.362): client pc 1.Clean dust from interior/exterior of computer chassis as needed.2.Verify proper function of keyboard, mouse, and touchscreen.3.Clean touchscreen per touchscreen manufacturer guidelines (use any brand name glass/surface cleaner but spray the rag, not the monitor, then wipe the monitor thus avoiding drips running into the monitor).Do not directly spray the touch screen surface.Hemo monitor pc 1.Clean dust from interior and exterior of computer chassis regularly.2.Ensure proper function of keyboard, mouse, and monitor.3.Clean the monitor displays (control room and x-ray procedure room (any glass or surface cleaner may be used but should never be sprayed directly on the monitor).

• 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: 7127623
• MDR Text Key: 95936941
• Report Number: 2183926-2017-00212
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1