MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE RADSUITE; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number MERGE RADSUITE V8.30.7.9 P1

Device Problem Device Operational Issue (2914)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Per the investigation by merge support, based on the examples provided by the customer, it appears that the studies were ordered and sent in without a patient location.The patient location was later updated on the work list.However, the patient location wasn't updated on the long term archive because the study had already been routed to the archive prior to the update to the patient location.The studies are found and viewed from the worklist and patient location is an important field to this customer.The customer's workflow includes adding in patient location after an order has already been completed.Merge technical support assisted the customer by adding in a short (1 minute) delay between customer updates to the worklist and the related studies being sent to the long term archive.Based on information received from the customer, the short delay in sending updated reports to the archive has resolved the issue.

Event Description

(b)(4) provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.The system displays traditional 2d and reconstructed 3d radiological images using webenabled viewers over both local and wide area networks.The application provides workflow integration capabilities for health care enterprises, wherein: radiologists can view, annotate, and tag studies as diagnostically read.Referring physicians can view patient images and radiologists' annotations.Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.On (b)(6)2017, merge healthcare technical support was notified by a (b)(4) customer that procedures were not able to be performed causing a delay in treatment for 2 patients.Per the customer site, emergency department studies are typically read within 30 minutes however, there were two studies that were not read until the next morning.With merge (b)(4) not functioning as expected, there is a potential for a delay in diagnosis or treatment that may lead to harm.There was no reported harm to either patient a or patient b as a result of the delay.(b)(4).

• Brand Name: MERGE RADSUITE
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• 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 drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6665950
• MDR Text Key: 78450389
• Report Number: 2183926-2017-00129
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K05328124
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MERGE RADSUITE V8.30.7.9 P1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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