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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problems Failure to Power Up (1476); Power Problem (3010); Noise, Audible (3273)

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

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

The faulty ups unit was returned by the customer to merge healthcare on 03feb2017 for evaluation.The results showed that the batteries were defective and subsequently replaced.Upon replacing the batteries, the unit passed all qc testing and was then sent to service stock.Device labeling, hemo-5303 v9.40 user manual, addresses the potential for such an occurrence with statements such as, "if low voltage is detected, the pdm goes to battery power and an audible alarm sounds.".

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 ups (uninterrupted power supply) started clicking and then caused the hemo application to shut down during a pacemaker placement procedure.Information obtained from the customer revealed that upon failure of the ups unit, the user plugged the hemo system into a wall outlet and then waited for the system to reboot.While waiting, the patient was connected to and monitored with an external defibrillator and a monitor for bp (blood pressure) and saturation levels.The delay was ~10-15 minutes and the procedure was completed successfully using the hemo monitoring system once operational.The loss of power to the hemo monitor resulted in a loss of patient monitoring for ~5 minutes.If parts of the hemo system become energized, there is a potential for direct harm to the patient and/or user including electrical shock or burns.There was no harm to the patient and/or user as a result of the clicking ups.With merge hemo not capturing physiological data, there is a potential for delay of treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo system 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: 6346559
• MDR Text Key: 68039628
• Report Number: 2183926-2017-00037
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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