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

Model Number MERGE HEMODYNAMICS 9.40.3 PATCH 1

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Transmit Record (1521); Device Issue (2379)

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

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts between the customer and merge technical support, the customer stated that when the hemo monitor froze, the pdm (patient data module) would buzz.The medical staff checked the +5v and +12v led's and both were lit when the pdm buzzed.The hemo monitor was rebooted a couple of times and eventually the hemo system started back up on its own.The medical staff confirmed to merge technical support that all cable connections were properly connected.Replacement hardware (rma #12714), a hemo monitor pc fru t3610, was shipped to the customer on 13jul2017.The faulty unit was received by merge healthcare on 18jul2017 for evaluation.The results showed that the unit contained an older serial card and was subsequently replaced with a lava brand serial card.The hard drive was also replaced and it passed all diagnostics testing.The unit was reloaded with software, it ran for five (5) days without issue, and was then sent to service stock.It was noted that the customer retained the unit's old hard drive so that phi (protected health information) would remain secure.It was found that the customer's reported problem is related to a previous internal investigation conducted by merge healthcare (hemo-6542).The problem occurs due to the serial port interface contained within the hemo pc that causes intermittent connection with the pdm.The resolution is to replace the older serial cards with lava brand serial cards.(b)(4).

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) 2017, a customer reported to merge healthcare that the hemo monitor froze about sixty (60) minutes into a procedure and continued to freeze every fifteen (15) minutes thereafter.The medical staff successfully completed the procedure using third party monitoring.The patient's data was manually charted and then added into the hemodynamics software for study report creation.With merge hemo not capturing physiological data, there is a potential for delay of treatment that could result in harm to the patient.However, the procedure was completed successfully using third party monitoring.Reference complaint-(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 6769862
• MDR Text Key: 82025235
• Report Number: 2183926-2017-00162
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2017
• 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 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1