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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The administrator manual has a caution "plaza_risk_docups", informing user to connect all system components to an uninterruptible power supply (ups).Another caution - "plaza_risk_docdatabasenotavailable" - exists to indicate the need to maintain backup to avoid data loss during hardware failures.No consequences have been reported from this customer.

Event Description

Siemens became aware of data loss caused by a hardware maintenance issue.Our factory experts evaluated the reported issue with no risk for the product with potential risk for the user.The drives d:\ (installation drive -virtual), f:\ and g:\ on the syngo.Plaza server were either not accessible or empty.Five hdd's were found to be defective on the storage/datastore for the plaza vm, which is configured from rhdassrv1.These drives hold the partitions of the syngo plaza server.Nas1 server/long term storage (lts) has 2 hdd's not accessible/empty as well.Total of 7 hdd's are either defective/empty or not accessible by servers.All prior information is lost.Clinical diagnosis may be potentially affected as old archived data is not available to prior comparison.The reported data loss was not related to the syngo.Plaza.There are no injuries attributed to this event.The reported incident occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8842252
• MDR Text Key: 188867620
• Report Number: 3002808157-2019-91115
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K132532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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
• Date Manufacturer Received: 07/16/2019
• 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