MAUDE Adverse Event Report: SIEMENS AG SYNGO.VIA; PICTURE ARCHIVING AND COMMUNICATIONS

Model Number 10496180

Device Problems Computer Software Problem (1112); Incorrect Error Code (2963)

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

Event Date 07/30/2014

Event Type  malfunction  

Event Description

Orientation labels are not printed out in printouts on the syngo.Via system.The labels are not printed when image text is set to none.Even though the orientation labels are displayed during the print preview, they do not show on paper.These images cannot be used for diagnostic or treatment purposes as users require textual info including orientation label to read the images.This issue was identified internally at the (b)(6), and no negative outcome has been reported neither from the customer nor from the installed base.

Manufacturer Narrative

Our factory experts conducted an investigation of the reported issue and determined that the issue occurs due to a software error.Due to the software error the system does not consider the orientation labels during printout process.The issue will be resolved with a software fix.Users were advised about a workaround to avoid the reported issue.This report was submitted 09/26/2014.

• Brand Name: SYNGO.VIA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS
• Manufacturer (Section D): SIEMENS AG; henkestrasse 127; erlangen 9105 2; GM 91052
• Manufacturer (Section G): SYNGO INTERNAL; electronics city; bangalore 5601 00; IN 560100
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4333663
• MDR Text Key: 5251604
• Report Number: 2240869-2014-07537
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10496180
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1