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

Model Number MERGE HEMODYNAMICS 9.30

Device Problem Power Problem (3010)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

First occurrence: at the customer's request, a spare trunk cable was shipped to the site for additional troubleshooting (rma (b)(4)) along with the assistance of a mera (medical equipment repair associates) technician so that a faulty trunk cable could be ruled out.Upon connection of the spare trunk cable, it was confirmed that there was still no power to the unit.It was determined that a fuse had blown on the pdm (patient data module) and was subsequently replaced.The customer confirmed that the issue was resolved.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence as noted in the following sections: communication - record station: person icon - "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." led behavior section: "5 v led 4.5 to 5.5 v: if it drops below or if there's a blown fuse on the hemo monitor pc's pci card, the led goes out." general equipment care section: "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." no further actions are anticipated at this time due to the issue being readily apparent to the user, troubleshooting information provided in the user manual, and the potential non-serious injury to a patient.(b)(4).

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, a customer reported to merge healthcare that the person icon located within the hemo application was flashing indicating a disconnection between the hemo monitor and pdm (patient data module).This occurred during a procedure and resulted in the use of portable blood pressure monitoring and third party equipment to capture the patient's invasive pressures.Additional information obtained from the customer revealed that the problem occurred twice on different days, (b)(6) 2018.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.However, the customer confirmed that both procedures were completed successfully by using third party equipment.(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: 7766076
• MDR Text Key: 117019697
• Report Number: 2183926-2018-00070
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 00842000100010
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.30
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2013
• 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