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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problems Failure to Transmit Record (1521); Blocked Connection (2888)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem is currently being evaluated by merge healthcare.(b)(4).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) 2016, a customer reported to merge healthcare that the hemo monitor froze during a procedure resulting in no arterial pressure.Subsequently, the hemo monitor was rebooted resulting in a loss of patient monitoring.During this time, the patient was connected to an external defibrillator so that the procedure could continue.With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatments that results in harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted and the medical staff was able to capture the patient's arterial pressure.(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 30sep2016.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Merge technical support shipped the customer the following replacement hardware: hemo pc fru (rma #10868) - shipped to the customer on (b)(6) 2016.The faulty unit was returned to merge healthcare on (b)(6) 2016 for evaluation.The results showed that no problems were found after full system diagnostics testing was performed.Software was reloaded and the unit ran for five (5) days without issue.V2 4p masimo nibp 2.X pdm (patient data module) [rma #10779] - shipped to the customer on (b)(6) 2016.The faulty unit was sent to the manufacturer for evaluation and received by (b)(6).The manufacturer's results showed that no problems were found.The unit passed all testing and was returned to service stock by merge healthcare.V2 4p link asembly (rma #10871) - shipped to the customer on (b)(6) 2016.The unit was returned unopened and unused to (b)(6).Coiled cable (rma #10870) - shipped to the customer on (b)(6) 2016.The faulty cable was scrapped onsite by the customer.No evaluation could be performed.100' trunk cable (rma #10872) - shipped to the customer on (b)(6) 2016.The faulty cable was scrapped onsite by the customer.No evaluation could be performed.Upon installation of the replacement hemo pc and pdm, the freezing still occurred during testing.Merge technical support shipped the customer the replacement 100' trunk cable that was temporarily placed on top of the floor and connected to the hemo pc and pdm to determine if it was the cause of the freezing issue.The hemo components were tested for several days without issue so the conclusion was made that the trunk cable was faulty.It was then permanently placed under the floor by the site's it employees per merge healthcare's recommendation.Since the trunk cable was scrapped onsite by the customer, no evaluation could be performed.Device labeling, hemo-5373 v9 user manual, addresses the potential for such an occurrence in the general equipment care section that states, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." no further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious injury assessment to a patient, and the recommendation provided in the user manual to check all cabling.Revised information contained in this supplemental report includes the following: indication that device available for evaluation (date last piece of equipment received).Updated contact office - name/address.Date new information received by manufacturer (rma closure date).Indication that this is follow-up report 001.Indication of malfunction as reportable event.Indication of additional information and device evaluation.Indication that device evaluated by manufacturer.Evaluation codes: methods code#1: 10 - actual device evaluated (hemo monitor and pdm).Methods code #2: 3263 - actual device not evaluated (100' trunk cable).Results code #1: 213 - no failure detected (hemo monitor and pdm).Results code #2: 3221 - no results available since no evaluation performed (100' trunk cable).Conclusions code #1: 71 - no failure detected, device operated within specification (hemo monitor and pdm).Conclusions code #2: 70 - device discarded by user, unable to follow-up (100' trunk cable).Indication of additional manufacturer information is 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: 5990490
• MDR Text Key: 56041633
• Report Number: 2183926-2016-00745
• 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: 08/31/2016

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 9.40.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: 11/01/2016
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1