MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO.PLAZA; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10863171

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

The syngo.Plaza works according to specification as the syngo.Plaza sent as error status to scu (modality) for the corrupted images.The scu should have resent the images to the syngo.Plaza.In this case syngo.Plaza application worked as specified.No consequences have been reported, neither from this customer nor from the installed base.Internal id # (b)(4).

Event Description

Siemens became aware of an incident on the syngo.Plaza unit.The log files showed multiple instances of abnormal shutdown (power outage or windows blue screen/bsod issues) of the machine, while receiving the images from the modality.Due to this interruption in file transfer process, the image files were not successfully stored to the local file system, resulting in archive failure and loss of physical files.As of december 18, 2019, total number and time period of missing data are as follows: total # of images lost - 72, total # of studies affected - 14, affected studies are dated 2018 and 2019.There was no injury associated with the issue.The reported event occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9495106
• MDR Text Key: 219909829
• Report Number: 3002808157-2019-06586
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K132532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10863171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other