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

Model Number MERGE CARDIO 9.0.8

Device Problems Installation-Related Problem (2965); Data Problem (3196)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

An internal investigation (b)(4) was initiated that included merge healthcare remotely accessing the customer's cardio application system (cas).It was found that the configuration for the pdf header display, used to print out the patient studies, had not been activated.This caused the patient identifiers (patient name, patient id, and study date/time) to only appear on the first page.The problem was identified as the "pdfheaderdisplayonoddpages and pdfheaderoptionsshowonevenpages" were set as "false" indicating that these page headers were not activated.Once identified, the correct pdf header display was set to "true." additionally, the reports had footers that showed "page x of y" which assists individuals reviewing reports to know if all pages are accounted for.The reported problem is site specific since network configurations are customized based on a site's needs.

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 reported to merge healthcare that the headers on echo and stress echo reports containing unique identifying information (patient name, patient id, and study date/time) was only viewable on the first page of the report and was not included on any subsequent pages.When merge cardio does not provide the correct unique identifier in the header of a patient's report, there is a potential for patient data to be compromised which could potentially lead to an incorrect treatment or diagnosis that may result in harm to the patient.Information obtained revealed that the user was aware of the problem, no patient data was compromised, and no patient harm occurred.Reference complaint number (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: 5720410
• MDR Text Key: 47239034
• Report Number: 2183926-2016-00601
• 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: Other
• Type of Report: Initial
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO 9.0.8
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2013
• 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