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 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Information obtained from the customer revealed that the site has called in to merge technical support on two (2) other occasions reporting a similar issue.These events have also met the criteria as a reportable event and have been captured in initial mdr reports #2183926-2017-00186 and #2183926-2017-00187.For this occurrence, it was found during troubleshooting efforts between merge technical support and the customer that there was a loose cable connection as well as a bad block on the hemo monitor hard drive.Merge technical support walked the customer through the steps to correct the bad block issue by running a "chkdsk f/" command.The loose cable was reconnected and it was confirmed that the bad block had been removed and connection was re-established.Device labeling, hemo-6373 v10 user manual, addresses the potential for a loose cable connection in the (b)(4) 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." two conclusions codes were used in this report: 19 (human factors issue - disconnected cable) and 13 (device difficult to operate - bad block on the hard drive).(b)(4).Methods code: actual device evaluated.Results code: interoperability program (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components.) conclusions code #1: human factors issue.Conclusions code #2: 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 hemo monitor froze in two (2) of the site's cath labs.It was reported that this issue has occurred multiple times with sedated patients causing a delay in care while preparing third party monitoring equipment to complete the procedures.However, the exact dates were unknown but it was reported that there were no adverse outcomes as a result of the freezing issue.Date of event, was completed with this known occurrence date.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 using a third party monitoring system capturing invasive pressures and vitals.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: 6943209
• MDR Text Key: 90312068
• Report Number: 2183926-2017-00185
• 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: 09/14/2017

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: 09/14/2017
• Initial Date FDA Received: 10/11/2017
• 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