MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

Model Number MERGE PACS 7.0.2

Device Problems Communication or Transmission Problem (2896); Loss of Data (2903)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare is continuing to investigate the issue and will determine if corrections or corrective actions are required.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2016 a customer reported that the communication notes were not saving.With merge pacs not saving communication notes as expected there is a potential for a delay in diagnosis or treatment that leads to harm.The customer did not allege an injury, the need for medical intervention, or adverse consequences as a result of the unretrievable images.(b)(4).

Manufacturer Narrative

The investigation of the reported issue found that merge pacs is functioning as designed.The comments were not being saved as that specific comment section is for documenting additional information for when and why a status is changing.The comments do not save when the status is not changed.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: mike diedrick ; 900 walnut ridge dr; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6165569
• MDR Text Key: 62385329
• Report Number: 2183926-2016-00816
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MERGE PACS 7.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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