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

Model Number MERGE CARDIO V10.2 PATCH 2

Device Problem Patient Data Problem (3197)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Information provided from the customer indicates that when the patient's report did not post to their hospital interface system (his), they did have alternative means of reviewing the report.A review of the customer's cardio software by merge healthcare's technical support staff indicated that a 'hung' application service prevented the patient's clinical report from being delivered to the customer's hospital interface system.Upon restarting the application service, support confirmed that clinical reports began flowing to the customer's hospital interface system normally.

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) 2017, a customer contacted merge healthcare and stated that on (b)(6) 2017 the merge cardio outbound hl7 interface had stopped sending clinical reports electronically to their hospital interface system for approximately 18 hours.During this downtime, a patient was discharged from the facility without a full review of the patient's clinical report.The customer stated that it was necessary for the patient to return to the facility for further testing.The merge cardio software provides users with the ability to review and print clinical reports when they are unable to be delivered to the customer's hospital interface system.Additionally, the system is designed to notify the user if the delivery of clinical reports fails.The notification allows the user to be made aware of report communication issues in order for other methods of communication to be used (print, scan, fax, etc.).With a patient being discharged before staff completed a full review of that patient's clinical report, there is a potential for a delay or incorrect treatment that could result in harm to the patient.However, the customer reported that no harm had occurred.(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: 6346513
• MDR Text Key: 68086471
• Report Number: 2183926-2017-00040
• 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: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.2 PATCH 2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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