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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Incorrect Measurement (1383); Failure to Zero (1683); Device Operational Issue (2914)

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

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned by the customer to merge healthcare for evaluation as of 23may2017.When more information becomes available, a supplemental report will be submitted.

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 a pressure chanel would show real pressures.It was reported that the patient was moved to another room onsite.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 another lab.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 24may2017.During troubleshooting activities, the customer reported to merge technical support that the pdm (patient data module) in their cath lab 2 would not zero and was "throwing out numbers." the medical staff then decided to move the patient to a known working lab.Merge technical support shipped the customer a replacement v2 4p masimo nibp 2.X pdm on 24apr2017.The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 08may2017.The manufacturer's evaluation results showed that the customer's reported problem, failing pressure channel/port 1, could not be duplicated.The unit underwent testing and passed and no failure was detected.For this reason, conclusion code 71 (no failure detected, device operated within specification) was used.A review of the customer's hemo case management within merge healthcare's internal database on 01jun2018 found that the customer called in again on (b)(6) 2017 reporting a similar issue in their cath lab 1 ((b)(4)).Hardware evaluation results revealed that the customer's reported problem, unit would not stay powered on, could not be confirmed.Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section which states, "problem: the application will not allow user to zero pressure.Resolution: ensure that the transducer is plugged in and open to air.Make sure the cable connection is clean.Switch cable to different channel.If problem persists, contact technical support." additionally, the cardiac output check section provides the user detailed instructions on how to properly use the test plug when testing the cardiac output function.No further actions are anticipated at this time due to the issue being readily apparent to the user, the low number of customer complaints for the reported issue, and no known impact to the patient.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: device code #1: 2914 device operational issue (correction).Device code #2: 1683 failure to zero (correction).Methods code: 10 actual device evaluated (blank in initial report).Results code: 213 no failure detected (correction).Conclusions code: 71 no failure detected, device operated within specification (correction).H10 - indication of additional manufacturer information and corrected data are contained in this follow-up report.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 6586823
• MDR Text Key: 75817340
• Report Number: 2183926-2017-00113
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE HEMODYNAMICS 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1