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

Model Number MERGE CARDIO V10.3.1

Device Problem Data Problem (3196)

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

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

During investigation it was found that the customer requested to have the ivsd measurement mapped.The reporting engineer activated the measurement in both production and test and tested that the measurement displayed by manually entry into cardio reporting.The customer asked the techs to test to make sure the measurement was mapping as expected but they found the value was not what was expected.The customer called cardio support to look into the issue.Support found that 2 mapping strings were connected to the measurement and the unintended string was the actual string that was mapping.Support inactivated the unintended mapping string to resolve the issue.This issue was readily apparent to the customer as they were checking to ensure proper mapping when this incorrect value was found.The customer stated no patient harm was reported due to this issue and with the configuration change made by merge cardio technical support that the issue has been resolved.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue and it has been resolved.

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) 2018, a customer contacted merge healthcare and stated that diagnostic measurements taken by their modality needed to be corrected.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.(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: meg mucha ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123514
• MDR Report Key: 7775806
• MDR Text Key: 117285903
• Report Number: 2183926-2018-00073
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: 00842000100041
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.3.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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