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

Model Number MERGE HEMODYNAMICS 10.0

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

Patient Problem Missing Value Reason (3192)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare remotely accessed the customer's data logs and no errors were found.Further inquiry with the site revealed that the problem could have been caused by a power surge.Merge went to the customer site to conduct power frequency magnetic field testing.The results showed that all four (4) hemo stations shutdown.Three (3) out of four (4) hemo stations could not be powered back up.It was found that the site's power sensitivity was too high.Replacement ups (uninterrupted power supply) units were installed and the equipment was tested without further issues.Instructions for use, hemo 10 user manual, addresses the potential for such an occurrence in the section for manufacturer declaration for electromagnetic immunity with statements such as, "immunity test: voltage dips, short interruptions and voltage variations on power supply input lines iec 61000-4-11 electromagnetic environmental guidance: mains power quality should be that of a typical commercial or hospital environment.If the user of the system requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptible power supply or a battery." (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) 2016, a customer reported to merge healthcare that the hemo application froze during an active case.Information obtained from the customer revealed that the patient had already been sedated and connected to active monitoring.Subsequently, the medical staff cancelled the procedure and rescheduled it for a later time.With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatment due to no display of data that results in harm to the patient.There is no indication of an adverse event due to the issue alleged by the customer.(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: 5801429
• MDR Text Key: 49745344
• Report Number: 2183926-2016-00636
• 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: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2016
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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