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

Model Number MERGE HEMODYNAMICS 10.0

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

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

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

Merge technical support shipped the customer a replacement hemo pc fru (rma #14247) on 01may2018.The faulty unit was returned to merge healthcare on 07may2018 for evaluation.The results showed that the customer's reported problem, hemo monitor black screening, could not be duplicated.The hard drive was wiped of all phi (protected health information) and full system diagnostic testing was performed.No failure was detected.Software was reloaded onto the unit and it ran for one (1) week without issue.The unit was tested according to hemo-11245: hemo 10.1 hemo monitor production install and test procedure.Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section with statements such as, "problem: there is no communication between hemo monitor pc and client.Resolution: check that the crossover cable from the client to the hemo monitor is plugged in properly and lights are on.Reboot the hemo monitor pc.Exit and reopen the study.Answer yes to is patient still being monitored.Check that the client is properly configured to use the hemo monitor pc (in system config).If none of these work, contact technical support." additionally, the user is reminded in general equipment care to "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." the potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).No further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious patient impact, and the recommended equipment inspection per the user manual.(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 hemo monitor display turned black during a procedure.Information obtained from the customer revealed that the problem occurred after sedation and active monitoring had been started.The customer also stated that there was no harm to the patient during this time.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could result in harm to the patient.However, the customer reported that the procedure was completed successfully using a philips defibrillator 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: 7535994
• MDR Text Key: 109500999
• Report Number: 2183926-2018-00041
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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