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); Data Problem (3196)

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

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare.For this reason, conclusions code 11 (conclusion not yet available-evaluation in progress) was used.When more information becomes available, a supplemental report will be submitted.(b)(4).Conclusions code: conclusion not yet available-evaluation in progress.

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) 2017, a customer reported to merge healthcare that the hemo monitor and client pc display monitors turned black (went blank) during a stemi (st elevation myocardial infarction) procedure.Subsequently, the patient was moved to another onsite lab.The delay time was ~10 minutes in order for the patient to be moved and the other lab to be prepped.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.However, the procedure was completed successfully once the patient was moved to another onsite lab.(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 06sep2017.During troubleshooting efforts, the customer reported to merge healthcare that the power supply to the video splitter was very loose and the power connector fell out with very little effort.The other two (2) onsite labs were checked and the same issue was found.This problem requires the user to tighten the connector and cabling.After investigating, it was found that the issue occurred on a nurse's workstation and client pc and the hemo monitor was not affected.Since the hemo monitor and client pc are separate units that operate independently of one another, the patient's data could have been captured using manual charting and then added to the chronlog at a later time.Therefore, the medical staff could have continued the procedure without the necessity of moving the patient.In addition, the nurse's workstation is used outside of the cath lab and its malfunction has no impact to a patient during a heart catheterization procedure.Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence as stated in general equipment care, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." in addition, the user manual states, "ancillary workstations may be udr or hemo.Ancillary workstations offer access to the application for functions of patient studies outside of the catheterization lab.Such functions include entry of patient data, the monitoring of patient vitals pre and post procedure, and the management of equipment inventory and system configurations.Ancillary workstations are connected to the server via network cables and consist of the workstation pc which may be connected to a supported third-party patient monitor." no further actions are anticipated at this time due to the issue being readily apparent to the user and the low impact to a patient.Revised information contained in this supplemental report includes the following: g4 - date new information received by manufacturer (case closure date) 10/08/2017.H6 - evaluation codes: methods code: 10 actual device evaluated.Results code: 3227 power source problem (problems that are related to the device that provides power).Conclusions code #1: 19 human factors issue.Conclusions code #2: 51 maintenance deficiency (device problems that result from improper routine or preventative maintenance).H10 - 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: 6847485
• MDR Text Key: 85137590
• Report Number: 2183926-2017-00174
• 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: 08/09/2017

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 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 10/08/2017
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1