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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

The potential impact to a patient has been reviewed and the severity level has been assessed as medium (non-serious injury).During troubleshooting activities between merge technical support and the customer, it was reported that the issue occurred during a procedure where the patient was mildly sedated.There were no reports of patient harm as the procedure was completed using a spacelab monitoring system in place of merge hemodynamics.Merge technical support shipped the customer a replacement pdm (patient data monitor) on 18sep2018.The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 26sep2018.The manufacturer's evaluation results showed that a spent battery was found and subsequently replaced.The unit was re-certified and returned to merge healthcare.Upon receipt, the unit was tested according to hemo-5927 (hemo patient data monitor build and test procedure) and it passed.Upon receipt of the replacement hardware, the customer confirmed that the issue was resolved.A review of the customer's hemo case management within merge healthcare's internal database found that there have been no other reports of this issue as of 09oct2018.No further actions are anticipated at this time due to the issue being readily apparent to the user, the potential non-serious impact to a patient, and the multiple labs available for use at the site.(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 september 18, 2018, a customer reported to merge healthcare that the patient data module (pdm) did not display waveforms during a procedure.This resulted in the use of a third party monitoring system.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that could cause harm to the patient.However, the customer confirmed that the procedure was completed successfully using third party equipment.(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: 7982022
• MDR Text Key: 124672021
• Report Number: 2183926-2018-00086
• 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: 09/18/2018

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 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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