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

Model Number MERGE HEMODYNAMICS 9.30

Device Problems Failure to Transmit Record (1521); Data Problem (3196)

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

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

Merge technical support provided assistance for the customer to troubleshoot the reported problem by using the simulator to test the connection after the cables, probe, and swan catheter were replaced.When an error occurred after connecting the cables, the user was instructed to try another cable (to rule out a faulty cable) but the same error message appeared.After reusing the simulator for a second time, the readings were displayed correctly.It was found that the system needed cycle time to reset itself.The customer confirmed that the system was functioning as intended.Hemo user manual, addresses such an occurrence with statements such as, "if injectant reads cable off or low<0.5 and distal reads cable off or high>43.0 either the cardiac output cable is not connected to the pdm, the swan is not connected to the cardiac output cable, or the probe/in-line cable is not connected to the cardiac output cable.All must be connected and the correct type selected in the action editor in order to get valid numbers and obtain valid cardiac outputs." further, the user manual states in the general equipment care section, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." for this reason, conclusions code 19 (human factors issue) was used.

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 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) 2016, a customer reported to merge healthcare that an error message was received by the user that stated "cable off." information obtained from the customer confirmed that a patient was moved to another room after sedation and active monitoring began as a result of the reported problem.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, the customer reported that the procedure was completed successfully once the patient was moved.(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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5849144
• MDR Text Key: 51233817
• Report Number: 2183926-2016-00674
• 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: 07/05/2016

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 9.30
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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