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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problems Computer Software Problem (1112); Device Issue (2379)

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

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The problem reported by the customer is a known issue with the hemo system when the patient data module (pdm) has been disconnected and then restarted.The available information suggests that the problem arose from the site's recent renovations to their facility that caused the hemo system to be disconnected from its power source.Specific instructions have been included in the product instructions for use (ifu) as well as a distributed customer bulletin explaining the correct on/off power sequence (b)(4).When these specific instructions are not followed, the reported problem will be experienced by the user.There is no indication that this event is due to product malfunction but rather the user not following instructions.

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 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 hemo monitor pc via the serial interface.All data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that there was a problem activating full disclosure recording for an active case and showed grayed-out icons on the top tool bar.This resulted in moving the patient to another functioning lab onsite.It was further reported that there had been recent renovations at the facility that suggest the hemo system was disconnected from its power source.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, it was reported that the procedure was completed successfully once the patient was moved to another lab onsite.Reference complaint number (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; harland, WI 53029 ; 2629123570
• MDR Report Key: 5509397
• MDR Text Key: 40639638
• Report Number: 2183926-2016-00496
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Removal/Correction Number: 2183926-02/15/2016-041-C
• Patient Sequence Number: 1