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

Model Number MERGE PACS 7.0.2

Device Problem Use of Device Problem (1670)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare technical support further investigated the issue and determined that the customer had a setting, overwrite future status, set to "no." this setting when set to "no" will not change the status of studies that have been read even if new images are received or added to the study.With the customer having this setting configured off, there are other possible indicators where the end user can be notified about additional images: the tech should have informed doctor of additional images that were sent three minutes after original batch.The radiologist should have noticed the study description and labeled.As "head/cervical" but only read reviewed images of the head.The er doctor ordered two scans and only received one report; each scan would have produced a separate report.Therefore, the doctor should have confirmed two reports, not just one.At this time, merge healthcare is working with the customer to change their setting to "yes" which will flip the status of the study when new images are received.Merge pacs software was working as designed.No further corrective action is needed at this time.

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 a patient was sent home with a cervical fracture because images were not read.The customer found the images missed review and contacted the patient.The patient was asked to go to the customer's main hospital for an mri.After the mri was performed, the customer had successful surgery.There is a potential for a delay in treatment or diagnosis which can lead to patient harm as a result of clinical staff not reviewing all images.It was determined that the patient received an mri scan and surgery prior to any additional harm beyond the original cervical fracture.(b)(4).

Manufacturer Narrative

The customer previously wanted to change their overwrite setting to "yes" which will flip the status of the study when new images are received.After further testing in their test environment, the customer confirmed they are keeping the current status set to "no" which will not update the study status if new images are received.The customer is aware of these risks and will use different measures to ensure if additional images are sent after the original study.Merge took further action to update the merge pacs upgrade and install instructions to remove any modifications of the overwrite status to ensure the setting remains the same as previously configured.If the customer chooses, they may have this setting turned on and off as needed.No further corrective actions will be taken at this time.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 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: 5763073
• MDR Text Key: 48632297
• Report Number: 2183926-2016-00625
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: 06/01/2016
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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