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

Model Number MERGE HEMODYNAMICS 10.0.1

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 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare.For this reason, conclusions code (conclusion not yet available-evaluation in progress) was used.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 problems were experienced with the hemo monitor freezing in the middle of an acute mi procedure after active monitoring and sedation had been initiated.Subsequently, the hemo monitor was rebooted that resulted in a loss of patient monitoring.The delay was ~10-15 minutes while the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted on (b)(6) 2017.During troubleshooting efforts between merge technical support and the customer, it was found that the video splitter had lost power.Once the splitter and hemo monitor were rebooted, it was confirmed that the hemo system worked as expected.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 this issue being readily apparent to the user, the non-serious impact to a patient, and the equipment care instructions provided in the user manual.(b)(4).

• 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: 6252144
• MDR Text Key: 64895222
• Report Number: 2183926-2017-00011
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1