MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE EYE STATION IMPORT UTILITY; MEDICAL DEVICE DATA SYSTEM

Model Number ESIU 1.0

Device Problem Data Problem (3196)

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

Event Date 06/28/2013

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.However, during internal investigation no customers in the us were identified or affected.

Event Description

Information in eye station medical image dicom fields may persist inappropriately from one image to another when one or more values in the new import file are empty, since empty values in the new file are not erasing the corresponding values in the previously imported file.The issue would only present itself if these specific conditions occur: a non-mandatory field is not present in an imported dicom image after the same field in a previously imported dicom file has been present, and both files are in the same import directory.If the physician does not notice the anatomy of the retina displayed in the image and relies solely on the text on the image, there may be a remote chance that patient injury could occur due to improper treatment.There were no injuries reported due to this incident.There are no devices in the field that are likely to cause injury.An issue relating to this defect would require the following conditions to happen: esiu is setup to receive dicom files for import.A non-mandatory field is not present in an imported dicom image after the same field in a previously imported dicom file has been present and both files are in the same import directory.Note that the two images could be from the same or from different patients.(patient name cannot be mixed up as it is mandatory though).The wrong value in this field in the second image is causing a wrong diagnosis.

• Brand Name: MERGE EYE STATION IMPORT UTILITY
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• 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: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5337578
• MDR Text Key: 35260606
• Report Number: 2183926-2015-00018
• Device Sequence Number: 1
• Product Code: NFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2015

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: Other
• Device Model Number: ESIU 1.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2013
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2013
• 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