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

Model Number MERGE HEMODYNAMICS 10.2

Device Problems No Device Output (1435); Unintended Application Program Shut Down (4032)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

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 notified merge healthcare support that a popping noise was heard and then smoke was smelled close to the merge hemodynamics unit in the site's ep lab.The customer further reported to support that the phillips display monitor, which is third party hardware, stopped working at the same time.Tech support instructed the customer to swap out a vga video splitter from another lab while waiting for replacement hardware.This happened at the very end of the case and the patient was not affected.The customer was able to finish the case prior to the issue.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).A supplemental report will be filed when further information becomes available.

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 10/28//2020.After additional troubleshooting by merge healthcare technical support, it was determined that the customer was using a large monitor with the hemo pc unit.The adapter was not correct for this large monitor and this caused the issue.There was no problem with the hemo pc unit or software, rather, the third-party component.The site was advised regarding correct adapter usage when using large monitors.The site was non-responsive several times and required several communications.No further action is required.Revised information contained in this supplemental report includes the following: 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.Component code: 423 cable, electrical.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 4203 electrical/electronic component problem identified.Investigation conclusions: 4307 cause traced to component failure.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 53029
• MDR Report Key: 10751459
• MDR Text Key: 213694865
• Report Number: 2183926-2020-00040
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100430
• UDI-Public: (01)00842000100430(10)10.2(11)190612
• 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: 10/28/2020

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 10.2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1