MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS

Model Number MERGE CARDIO V10.1.2

Device Problem Data Problem (3196)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation found that the left main coronary artery unit of measure was listed in mm.This was causing the z-score to incorrectly calculate.Once the unit of measure for left main coronary artery was updated from mm to cm, the knowledge base correctly calculated the z-score.As a work around, the customer elected to utilize another device to calculate the z-score that.In merge cardio, the default unit of measure for coronary arteries in the 3.4 and 3.5 echo.Peds knowledge bases is cm, this customer requested to have their kb to have the coronary arteries unit of measure as mm.This customization caused the z-scores to calculate differently than expected.The reporting engineer has corrected the issue and the customer confirmed in the test environment prior to moving to production.The customer has confirmed correct results in production.The customer was contacted and no patients received incorrect care based on the outcome of the calculations.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.On (b)(6) 2016, a customer contacted merge healthcare alleging that the left coronary artery z-scores were not calculating correctly in their echo.Peds clinical report.Due to an incorrect value displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm.The customer was contacted and no patients were treated incorrectly based on the outcome of the incorrect value.(b)(4).

• Brand Name: MERGE CARDIO
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• 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 dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5998947
• MDR Text Key: 56451299
• Report Number: 2183926-2016-00749
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• 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