MAUDE Adverse Event Report: DEXIS DEXIS IMAGING SUITE; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 1.008.7932

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The customer used a scenario which was not indicated in the dexis user manual.A software evaluation was performed on dexis 10.1.2.Evaluation revealed that the reported issue is only observed when multiple instances of dexis (patient) administration are active, which is not considered to be a normal scenario for the use of dexis.The issue can be resolved by reloading the patient list in the active dexis administration window.The user is able to determine the correct patient image and no injuries have been reported.This concludes our investigation.

Event Description

The customer reported that the incorrect patient is displayed when clicking directly on a patient name in the dexis (patient) administration screen.No injuries have been reported.

• Brand Name: DEXIS IMAGING SUITE
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): DEXIS; 1910 north penn road; hatfield PA 19440
• Manufacturer (Section G): DEXIS; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: martin rajchel ; 2800 crystal drive; hatfield, PA 19440 ; 2679540338
• MDR Report Key: 6180761
• MDR Text Key: 62684467
• Report Number: 2530069-2016-00012
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090431
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1.008.7932
• Device Catalogue Number: 1.008.7932
• Device Lot Number: 10.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• 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