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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problems Device Issue (2379); Device Operational Issue (2914)

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

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

To resolve the issue, it was determined that the coiled cable was unplugged.Once the coiled cable was plugged back in, the vitals displayed on the hemo monitor as expected.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Additionally, this event is typically recognized prior to the start of a case when the user is setting up equipment.The merge hemo user manual includes a guide on the communication between the pdm and the hemo monitor pc, equipment care guide, and tips on frequently asked questions.Per hemo-6373 merge hemo 10 user manual: (p.54), communication, record station.When a command is issued by touching or clicking an icon on the client pc, the hemo monitor pc responds.Physiologic monitoring is accomplished by these two computers joined via unique communication protocols.There are three icons on the bottom of the hemo monitor, left of the time display, that are displayed as visual indicators of system status.The patient name is displayed at the top of the screen and the day, date, and time are displayed at the bottom of the screen.(person) this icon appears to indicate communication between the hemo monitor pc and the patient data module (pdm).If there is a problem with any of the functions represented by the above three images, the icon color will switch to red.(p.363).Pdm: check the physical condition of the pdm and its cleanliness.Ensure that the calibration is current (according to the round sticker on bottom).If needed, order a replacement.Factory calibration is done before the unit is shipped.If the site requires the calibration of the unit to be checked, a transducer should be connected to a channel and 100 mmhg applied to the transducer with a mercury manometer.Ensure that it is within the ±1% tolerance that is allowed by the manufacturer.If the unit is outside of this specification, it should be returned.General: inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required.(p.378).Question: why isn't the system showing any waveforms or numbers? answer: check for the green light on the pdm and ensure the link is up.Check to see if any cables are disconnected.

Event Description

Merge hemodynamics displays, 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.The customer contact initially reported that on (b)(6) 2018 while a patient was on the table post sedation, the merge hemo client pc was not connected to the database (db).Troubleshooting from hemo technical support determined that the people icon was red indicating an issue with the connection from the patient data module (pdm).An alarm reset and full reboot of the client and hemo pc were completed while the patient was still sedated and being actively monitored.The customer then opened a case for the patient's record and the people icon was still red on the computer screen and the hemo monitor had no vitals with no lights illuminating from the pdm.The customer stated that a third party monitoring device was used while the hemo monitor was rebooted and the case was completed successfully.There was no indication of patient harm as a result of this issue.However, with merge hemo being rebooted and not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.Reference complaint number: (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: 7513313
• MDR Text Key: 108729632
• Report Number: 2183926-2018-00037
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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