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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problems Application Program Version or Upgrade Problem (2881); Device Operational Issue (2914)

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

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

Merge technical support remotely accessed the customer's system and found that the nic (network interface card) was connected at 100half that caused a duplex mismatching.The customer was notified of the finding and the site changed their network so the hemo monitor and client pc matched.However, on (b)(6) 2017, the customer called in again with the same problem.During remote access by merge technical support, it was discovered that windows defender was running on the client pc.Tech support disabled the software and rebooted the unit.The nic on the client pc was set to match the hemo monitor nic at 100full.During this time it was also found that the replacement hemo monitor previously shipped to the customer on 27dec2016 was preloaded with hemo software that had a different version than what the customer used.Since the software versions conflicted, it has been determined to be the root cause of the customer's reported problem for both occurrences.Once the version was downgraded to hemo v10.0.1 and (b)(6) disabled, the problem was corrected.The customer confirmed on 19jan2017 that the hemo system has been functioning correctly since (b)(6) 2017.Since the problem and resolution are the same but occurred on different dates, two (2) separate mdrs will be submitted.Reference mdr #2183926-2017-00022 for the second occurrence and event specific details.

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 in the middle of a procedure after active monitoring and sedation had been initiated and occurred on (b)(6) 2016.Subsequently, the hemo monitor was rebooted that resulted in a loss of patient monitoring.The delay was ~10-15 minutes while the hemo system rebooted.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 reported that the procedure was completed successfully once the hemo monitor was rebooted.(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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6284993
• MDR Text Key: 66007173
• Report Number: 2183926-2017-00021
• 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: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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