MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE UNITY PACS

Model Number 11.0

Device Problems Device Operational Issue (2914); Patient Data Problem (3197)

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

Event Date 06/09/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be an mdr.

Event Description

Merge unity pacs is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.Customer reported that a good numbers of reports have been missing headers.Reports are for distribution to referring physicians.If the patient demographics is missing and the report is distributed via fax or printer, the report could not be associated to any patient since no patient demographics are available.This event did not result in a serious injury to the patient.(b)(4).

• Brand Name: MERGE UNITY PACS
• Type of Device: PACS
• 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 rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437907
• MDR Text Key: 38219370
• Report Number: 2183926-2015-00432
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-063-C
• Patient Sequence Number: 1