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

Model Number UNITY PACS R11.0.455.12641

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Testing and investigation by merge support determined that the error "device: autoloader 1, hid-0 error code: 363 failed to start label re-transfer on everest printer; printer sense code = 254 (undefined sense code)" was likely related to the label/ribbon assembly.The customer found that the color ribbon (a part of the label/ribbon assembly) was out.Once the color ribbon was changed, the issue was resolved.A review of the merge unity user guides did not reveal any troubleshooting or other anomalies/issues regarding burning images onto a cd.A review of the complaint history indicates there is no significant trend.Trending will continue to be monitored.

Event Description

Merge unity pacs, a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.On (b)(4) 2017, merge was notified that on an unspecified date over the weekend of (b)(6), an error was received when attempting to burn images onto a compact disc (cd).The customer was not able to burn images of a computed tomography (ct) of the head/neck onto a cd from their rimage burner, which was needed for a patient being air-lifted to another facility.A patient was being evaluated in the emergency department for an attempted suicide.It was reported that the patient was unresponsive and intubated.The customer reported that the patient was air lifted to a pediatric trauma center in lubbock, tx in grave condition.As a result of the customer not being able to burn images onto the cd, the customer reported that another ct had to be performed at the hospital receiving the patient.There were no known adverse events to the patient.However, having to re-do a ct of the head/neck can delay patient care and/or diagnosis.In addition, this can expose the patient to additional unnecessary radiation.(b)(4).

• Brand Name: MERGE UNITY PACS
• 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: 6434929
• MDR Text Key: 70910669
• Report Number: 2183926-2017-00076
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041935
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNITY PACS R11.0.455.12641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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
• Patient Age: 14 YR