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

Model Number MERGE HEMODYNAMICS 10.0

Device Problem Connection Problem (2900)

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

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is currently waiting on additional information from the user so that the cause of the problem can be determined.Once the information is available, a follow-up 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 hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the pdm disconnected from the hemo monitor resulting in a 20 minute delay in starting an active case.This indicates that the patient had not yet been sedated.The user reported that an alarm sounded and then a red arrow appeared indicating a disconnection.The hemo monitor remained on but there were no waveforms or monitoring.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care and/or incorrect treatment that results in harm to the patient.However, the information reported by the customer indicates that the procedure was completed successfully once the hemo system was rebooted.(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 10apr2016.Troubleshooting efforts performed by merge technical support revealed that a power/signal loss that the customer heard only occurs when there is a power loss to the pdm (patient data module) at the procedure table and was indicative of the red arrow icon that appeared in the hemo application.Since the hemo monitor remained on, and only went down when the medical staff manually shut it down, there was no indication that the hemo monitor or its software were faulty.Additionally, the event logs were reviewed by merge technical support and no issues were found and no indication that the hemo monitor nor the software experienced any issues during this time.It was concluded by merge technical support that the pdm was disconnected and most likely caused from being forcefully bumped.The customer confirmed that the issue has not happened again.A review of the customer's hemo case management within merge healthcare's internal database confirmed that there have been no similar issues as of 16apr2018.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." also stated in the faq section, "question: why isn't the system showing any waveforms or numbers? answers: check for the green light on the pdm and ensure the link is up.Check to see if any cables are disconnected." for this reason, conclusions code 19 (human factors issue) was used.Revised information contained in this supplemental report includes the following: evaluation codes: methods code: 3372 analysis of data log(s) [analysis of device log data such as error or keystroke log, or device alarm history].Results code #1: 423 cable.Results code #2: 435 connector.Conclusions code: 19 human factors issue.Indication of additional manufacturer information is 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: 5566092
• MDR Text Key: 42273447
• Report Number: 2183926-2016-00532
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/10/2016
• Supplement Dates Manufacturer Received: 05/25/2016
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1