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

Model Number 10863171

Device Problems Use of Device Problem (1670); Loss of Data (2903); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The product syngo.Plaza did not contribute to the data loss in the sts.Folder deletion from the sts cannot be attempted from any of the syngo.Plaza workflows.If any image file is deleted from syngo.Plaza, it is logged in the application event logs.In the reported case there are no entries in the application event logs that suggest that the files have been deleted from the syngo.Plaza.Sts is intended only for temporary storage of patient data until it is transferred to long term storage (lts).No consequences have been reported, neither from this customer nor from the installed base.With this information, a death or serious injury is highly improbable.

Event Description

Siemens became aware of a data loss incident at the user's site.Siemens factory experts evaluated the reported issue within the acceptable risk threshold.Due to a deletion of folders from the short term storage (sts) partition of the syngo.Plaza server, belonging to 517 studies.With current available information, it is confirmed that the syngo.Plaza product did not contribute to the data loss in the sts.The storage of the image files was successfully completed upon receipt and the image files were properly stored (e.G.The series status is marked as complete).The images were present after storage.There are no injuries attributed to the event.The event occurred in the (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8532099
• MDR Text Key: 153110527
• Report Number: 3002808157-2018-41951
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10863171
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 04/19/2019
• 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