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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts between the customer and merge technical support, diagnostics were run on the unit by the customer and it was found that the hard drive contained errors: "error on validation hard drive short self-test failed error level 0." a replacement hard drive (rma # (b)(4)) was shipped to the customer on 01nov2017.The faulty unit was scrapped onsite by the customer which is the normal protocol so that phi (protected health information) would remain secure.The customer confirmed that the replacement hardware corrected this issue.A review of the customer's hemo case management within merge healthcare's internal database on (b)(6) 2017 confirmed that there have been no additional call-ins by the customer concerning this issue.(b)(4).Methods code: unit testing (testing of individual hardware or software components or groups of related units.) results code: interoperability program (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components.) conclusions code: device not returned.

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 froze during two (2) procedures on the same day but involved two (2) different patients.The first occurrence happened during a diagnostics-only procedure and the freezing/reboot occurred at the very end.The customer confirmed that no patient data was lost and the procedure was completed successfully.At that time, the hemo system automatically rebooted as designed.During a subsequent procedure and the second occurrence, the hemo system froze and then shut down again.There was a 10-15 minute delay while the medical staff waited for the system to reboot, however it did not reboot.This happened during a stent placement procedure and the patient had already been sedated and active monitoring was started.The medical staff used a defibrillator to capture the patient's invasive pressures.It was confirmed by the customer that the procedure was completed successfully.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 confirmed that both procedures were completed successfully.Reference complaint (b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 7051214
• MDR Text Key: 93299137
• Report Number: 2183926-2017-00206
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1