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

Model Number MERGE HEMODYNAMICS 9.40.1

Device Problem Electronic Property Issue (2928)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect hardware component is a ups, tripp lite 1000va, and a replacement was shipped from merge healthcare's (b)(4) site to the customer in february 18, 2016.The actual hardware was returned by the customer.Upon completion of the evaluation, no unusual noises were heard but the batteries appeared to be bad.

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 02/15/2016, a customer reported to merge healthcare that when the site's medical staff was abstracting data, the uniterrupted power source (ups) started making a "ticking" sound.A report of an overheated/malfunctioning ups can lead to a potentially hazardous situation for users and/or patients.The customer confirmed that there was no patient involvement and no user harm was reported.(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: 5501582
• MDR Text Key: 40394571
• Report Number: 2183926-2016-00488
• 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: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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