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

Model Number MERGE HEMODYNAMICS 10.2

Device Problems No Device Output (1435); Communication or Transmission Problem (2896)

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

Event Date 07/07/2020

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 a vga splitter became very hot and did not produce a video output signal upon attempt to install on the same day.This was an out of box failure so there was no patient involvement.A replacement 4 port vga video splitter extender was shipped to the customer on (b)(6) 2020.There have been no reports of patient injury 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 07/07/2020.The rma was processed on 2020aug26 by merge healthcare installation.The hardware investigation was performed by a whi implementation product specialist on 2020sep08 who noted the following: investigated the issue did not find an issue with excessive heat build up.The issue is a faulty or damaged connector on the power adapter.An intermittent connection could possibly cause heat build up if left for an extended period of time.The connection is intermittent, power to the splitter is lost and the green power indicator on the power adapter goes out when the connector or the wire to the connector is moved or disturbed.When the splitter is connected to a known good power adapter then no issue is observed.(test power adapter me testing area was used as a known good source) 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.There were no customer reports of this issue.Revised information contained in this supplemental report includes the following: 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 the performance of an electrical or electronic component was found to be inadequate.Investigation conclusions 4307 cause traced to component failure 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: 10247349
• MDR Text Key: 199899271
• Report Number: 2183926-2020-00023
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100430
• UDI-Public: 00842000100430
• 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: 07/07/2020

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: 06/15/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1