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 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently under investigation by merge healthcare.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) 2017, a customer reported to merge healthcare that the hemo monitor and client pc froze in the middle of a procedure after active monitoring and sedation had been initiated.Subsequently, both units were rebooted that resulted in a loss of patient monitoring.It was reported that the delay was a "few 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 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 04feb2017.Merge technical support contacted the customer to schedule time for remote access of their cath lab to investigate the reported issue.However, the customer did not respond to attempts to troubleshoot so the investigation is inconclusive and the complaint was unable to be confirmed.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).No further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to a patient, and the customer's non-response for troubleshooting assistance from merge technical support.Information contained in this supplemental report includes the following: device availability (device not available for evaluation).Mfr site - report source - updated contact office - name/address.Date new information received by manufacturer (supplemental report creation date).Indication that this is follow-up report 001.Indication of malfunction as reportable event.Indication of additional information.Indication that the device not evaluated by manufacturer.Evaluation codes: method: 3323 - no testing methods performed.Results: 3221 - no results available since no evaluation performed (for use when no methods were performed and therefore no results will be obtained.) conclusions: 67 - unable to confirm complaint.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: 6303002
• MDR Text Key: 66551024
• Report Number: 2183926-2017-00029
• 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: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2017
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1