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

Model Number MERGE HEMODYNAMICS 9.40.1

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 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Both of the faulty ups units were returned by the customer to merge healthcare on 02dec2016 for evaluation.The results showed that the batteries were defective and subsequently replaced.Upon replacing the batteries, the units passed all qc testing and were then sent to service stock.Device labeling, hemo 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) 2016, a customer reported to merge healthcare that the ups (uninterrupted power supply) was buzzing and caused the hemo application to shut down during two (2) procedures, each in different labs at the site.Information obtained from the customer revealed that upon failure of the ups units, the user immediately plugged the hemo system into a wall outlet and then waited for the system to reboot.The delay was ~10-15 minutes.This resulted in a loss of patient monitoring during the reported delay.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.However, the customer confirmed that there were no injuries to the patients or staff.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 procedures were 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: 6183834
• MDR Text Key: 62681178
• Report Number: 2183926-2016-00818
• 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: 11/17/2016

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 9.40.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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