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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting from hemo support determined that while they had a record station freeze, they were pushing group policies, structured query language (sql) updates, and mcafee scans.It was also noted that the client pc was running at 100% ram usage on only 2 gigabytes (gb).In addition, they were running numerous third party applications besides merge hemo.The resolution was to reboot the hemo monitor pc, client pc, and reset the pdm.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Per hemo-5303 merge hemo 9.40 user manual: 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 icon) this icon appears to indicate communication between the hemo monitor pc and the patient data module (pdm).(arrow icon) this icon appears to indicate communication between the hemo monitor pc and the client pc.(! icon) this icon appears only when there is a problem with any of the functions represented by the above three icons.It will flash, alternating with the normal icon.If this icon appears, contact technical support before continuing with the study.Record station:.Clean dust from the surrounding area including under the counter and around the record station enclosure.Client pc: 1.Clean dust from interior/exterior of computer chassis as needed.2.Verify proper function of keyboard, mouse, and touchscreen.3.Clean touchscreen per touchscreen manufacturer guidelines (use any brand name glass/ surface cleaner but spray the rag, not the monitor, then wipe the monitor thus avoiding drips running into the monitor).Do not directly spray the touch screen surface.Hemo monitor pc: 1.Clean dust from interior and exterior of computer chassis regularly.2.Ensure proper function of keyboard, mouse, and touchscreen.3.Clean the monitor displays (control room and x-ray procedure room (any glass or surface cleaner may be used but should never be sprayed directly on the monitor).Pdm: 1.Check the physical condition of the pdm and its cleanliness.2.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.

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.On (b)(6) 2018, the customer contact reported that the hemo monitor pc lost connection to the client pc during a case.Subsequently, all patient data from the current procedure was lost.A third party monitoring device was used to record patient vitals and invasive pressures.The resolution was to reboot the hemo monitor pc, client pc, and reset the pdm.However, it was unknown if this occurred during or after the case was already completed.The case was completed successfully and the customer confirmed that there was no harm to the patient.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.(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: 7887222
• MDR Text Key: 120738898
• Report Number: 2183926-2018-00081
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2018

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 9.40.1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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