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

Model Number MERGE HEMODYNAMICS V10.0.1

Device Problem Device Issue (2379)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/15/2016

Event Type  malfunction  

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 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 hemo monitor pc via the serial interface.All data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the site was experiencing a "reset" error on the ekg monitor and had 2-4 second breaks in the patient's ekg data that resulted in the loss of the data.The customer switched out the pdm cable and the problem was resolved.The customer has reported sporadically experiencing the flashing reset but have not experienced the ekg problem since the cable was changed out.This event has been attributed to a damaged pdm cable which resulted in device issue and loss of patient data.The device failed to perform an essential function which may lead to delay in diagnosis and/or treatment of patients.(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 16mar2016.Troubleshooting efforts between merge technical support and the customer found that the hemo monitor was rebooted but the problem persisted.The customer then removed the ekg leads from the patient and placed them on one of the medical staff and the ekg output worked correctly.It was concluded by merge technical support and the customer that either the leads were incorrectly placed on the patient or the lead strap was incorrectly placed.Device labeling (hemo-6373, v10 user manual) addresses the potential for such an occurrence in the troubleshooting section with statements such as, "problem: ecg error messages, resolution: several possible messages may appear on the hemo monitor if the system is unable to achieve reliable vitals readings.For example, if a lead is not properly attached to the patient or to the pdm, rather than offer a weak or inaccurate reading, the hemo monitor will indicate the affected lead with a lead off or not available message in white text.Check the lead's connection to the pdm and to the patient.Check for kinks or damage." revised information contained in this supplemental report includes the following: 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 and device evaluation.Indication that the device not evaluated by manufacturer.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
• 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: 5503564
• MDR Text Key: 40405484
• Report Number: 2183926-2016-00467
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

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 V10.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: 04/14/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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