MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH SIDEXIS 4; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Catalog Number 6618735

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation from the r&d department has resulted: sidexis 4 is used in combination with sidicom wls and a central pacs system.Sidicom wls is configurated to send automatically the images to the pacs system after the acquisition.Multiple sidexis 4 users at one windows pc's with individual user accounts logged-in, in parallel.After an examination the user does no logout of his windows session and a different user starts with his additional log-in.Additionally, sidexis 4 is not closed from the previous user.If the above listed conditions are given the issue described will occur.The immediate action is to add an additional instruction into the sidicom wls packages that are shipped.Further capa action is ongoing.

Event Description

X-ray images were additionally linked to wrong patient record.

• Brand Name: SIDEXIS 4
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9656563
• MDR Text Key: 184708034
• Report Number: 9614977-2020-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6618735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1