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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts between merge technical support and the customer, it was found that there was no power to the procedure table that holds the pdm (patient data module).The customer stated that the site's biomed replaced cables in the ceiling the day before.Once the cables were checked, the hemo system was rebooted and the connection issue was corrected.A review of the customer's hemo case management on (b)(6) 2017 by the qcs found that there have been no further call-ins by the customer regarding this issue or any other.Device labeling, hemo-6373 v10 user manual, addresses the potential for a loose cable connection in the faq section with statements such as, "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." (b)(4).Methods code: actual device evaluated.Results code: interoperability problem (a problem with the mechanical, electrical, or.Communication interface between two or more separate devices or components.) conclusions code: human factors issue.

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 connection between the hemo monitor and pdm (patient data module) was lost during a procedure.Subsequently, the patient was moved to a known working lab onsite after being consciously sedated.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the procedure was completed successfully once the patient was moved to a functioning lab onsite.Reference complaint-(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: 7034655
• MDR Text Key: 93087836
• Report Number: 2183926-2017-00202
• 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: 10/20/2017

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 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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