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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Communication or Transmission Problem (2896); Unintended Application Program Shut Down (4032)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2020

Event Type  malfunction  

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) 2020, a customer reported to merge healthcare that the hemo system went down during a procedure.The physiolog tabs were grayed out and hemo imaging was blue.Information obtained from the customer revealed that the hemo monitor had to be rebooted to re-establish connection.The patient was sedated and the catheter remained in the patient's heart during this time.It took ten (10) minutes for the hemo system to be accessible again.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer confirmed the procedure was completed successfully after the reboot.Troubleshooting efforts between the customer and merge technical support are ongoing.There have been no reports of patient inury or harm as a result of this issue.Reference complaint (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 5/12/2020.The faulty unit was received by merge healthcare on 02/08/2021 for evaluation.Testing results showed that the unit was returned unused after being at the customer site for 9 months.The unit's log shows it was never powered up by the site.The unit's hard drive was wiped and software was reloaded.It was tested and ran for 24 hours without issue and was then returned to service stock.The rma record was closed on (b)(6) 2021.No further action is required.Revised information contained in this supplemental report includes the following: g6 - indication that this is follow-up report 001.H6 - evaluation codes: health effect - clinical code: 4582 no clinical signs, symptoms, or conditions.Health effect - impact code: 2199 no health consequences or impact.Medical device problem code: 4032 unintended application program shutdown.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 104 software problem identified.Investigation conclusions: 143 quality control deficiency.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland, wi
• MDR Report Key: 10049483
• MDR Text Key: 195622767
• Report Number: 2183926-2020-00018
• 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: 05/12/2020

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
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1