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

Model Number MERGE HEMO V9.40.1

Device Problem Device Issue (2379)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Based upon available information, there is no indication that the reported event was related to a product malfunction or defect.This occurrence happened on one reading and for one patient only.The system was rebooted and the issue has not happened again.

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 having problems with ecg double counting during an active procedure.The system was marking the r-wave but it was marked on the base line.In addition, while using media contrast, there were 3 entries that were given.With merge hemo not presenting correct physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.(b)(4).

Manufacturer Narrative

The initial report submitted to the fda on 16mar2016 stated, "based upon available information, there is no indication that the reported event was related to a product malfunction or defect.This occurrence happened on one reading and for one patient only.The system was rebooted and the issue has not happened again." an internal investigation was completed by merge healthcare (hemo-7495) and it was found that the r-waves were not marked correctly as evidenced by photographs supplied by the customer and by viewing an r-wave recording.The r-wave pattern had intermittent duplication of r-waves and this behavior could continue throughout the recording.This duplication of r-waves could result in an inaccurate heart rate or invasive blood pressure value.These values are used in calculations which could then result in inaccurate data.Based on the duplication of r-waves and the affect on values and calculations, the issue is readily apparent to a trained user.To resolve the issue at the time it is recognized, the user will have to manually deselect the duplicate r-waves.The issue, which is readily apparent, does not pose patient safety concerns.The potential impact to a patient has been reviewed and the risk level has been assessed as low (non-serious injury).Additionally, a low number of customers have reported this issue therefore reducing the frequency of occurrence.The merge hemo user manual includes instructions on how to remove unwanted r-wave markings.Device labeling, hemo-5303 version 9, addresses the potential for such an occurrence in the pressure tab section with statements such as, "beats - selected beats from computerized calculations may be eliminated, such as catheter whip and respiratory variation.The computer detects the r-wave in the ecg and places gray lines through the area in the pressure waveform.The system uses the spaces between these lines to calculate gradients and analyze pressures.Proceed to r-wave for correction if necessary." no further actions are anticipated at this time due to the issue being readily apparent, the low number of complaints, the ability to correct the issue per the user manual and low impact on patients.Revised information contained in this supplemental report includes the following: mfr site: updated contact office - name/address.Date rec'd by mfr: date new information received by manufacturer (date of case closure).Type of report: indication that this is follow-up report 1.Type of report: indication of malfunction as reportable event.If follow up, what type?: indication of correction, additional information, and device evaluation.(b)(4).Indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5505093
• MDR Text Key: 40528107
• Report Number: 2183926-2016-00483
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMO V9.40.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1