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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problems No Device Output (1435); Output Problem (3005)

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

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Replacement hardware, v2 4p nellcor nibp 2.X pdm (patient data module) through rma #(b)(4), was shipped to the customer on 28jan2020.However, the faulty unit has not been returned to merge healthcare for evaluation as of 18feb2020.When more information becomes available, a supplemental report will be submitted to include hardware evaluation results and troubleshooting activities performed by merge healthcare.(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) 2020 a customer reported to merge healthcare that a patient's vitals did not display on the hemo monitor where data is captured and transferred to the user interface.A patient was present and as a result of the patient's vitals not being displayed on the hemo monitor, the patient was moved by clinical staff to another on site lab after sedation had been administered.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in treatment that could result in harm to the patient.However, the customer reported that the procedure was completed successfully once the patient was moved.(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 02/19/2020.Merge healthcare support tech support created rma #17775 and a replacement v2 4p nellcor nibp 2.X pdm (patient data module) was shipped to the customer on 2020jan28.The customer reported to tech support on 2020feb18 that the replacement hardware corrected the issue.Repeated attempts have resulted in no receipt of the original pdm by merge healthcare to further investigate, but the site reports no further issues.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer.G6 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H2 - indication of additional information.H3 - indication that device evaluated by manufacturer.H6 - evaluation codes: health effect - clinical code 4582 no clinical symptom/sign.Health effect - impact code 2199 no health consequences or impact.Medical device problem code 1435 no device output.Type of investigation 10 testing of actual/suspected device.Investigation findings 3221 no findings available.Investigation conclusions 67 no problem detected.H10 - 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
• MDR Report Key: 9729269
• MDR Text Key: 200606312
• Report Number: 2183926-2020-00005
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1