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

Model Number MERGE HEMODYNAMICS 9.40.2

Device Problems No Display/Image (1183); Connection Problem (2900)

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

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported to merge technical support that the provided test plug was used and the unit still did not connect to the hemo monitor pc.It was further confirmed that the pdm powered up correctly and all the connections were checked.A technician was deployed to the site to replace the faulty unit.Testing was performed and it was confirmed that the replaced unit worked as expected.The faulty device was sent to the manufacturer for evaluation and testing.The unit was received by merge healthcare on 23aug2017.The manufacturer's evaluation results showed that the unit's power connector was faulty and subsequently replaced.(b)(4).Methods code: actual device evaluated.Results code: power source problem.Conclusions code: device difficult to operate.

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) 2017, a customer reported to merge healthcare that the pdm (patient data module) would not connect to the hemo monitor pc prior to a procedure starting.Subsequently, the procedure was completed using a third party monitoring system.The brand and type of equipment was not divulged to merge healthcare.Information obtained found that the site has multiple labs but chose to perform the procedure in this lab anyway.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could result in harm to the patient.The customer reported that procedure was completed successfully with the external monitoring system.(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: 6847509
• MDR Text Key: 85746221
• Report Number: 2183926-2017-00175
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2014
• 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