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 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The syngo.Plaza is working as designed and intended; the reported data loss was unrelated to the syngo.Plaza product.The system is equipped with preventative caution - plaza_risk_docdatabasenotavailable - that indicates the need to maintain backup to avoid data loss during hardware failures.The syngo.Plaza product did not contribute to the partial data loss at this site.No consequences have been reported the user.Customer's address: (b)(6).

Event Description

Siemens became aware of data loss on the syngo.Plaza system.The initial issue of hardware recovery and operational systems/database restoration was reported under mdr # 2240869-2019-69334, however, it was later recognized that approximately 900 studies dating to the timeframe 2016 - 2019 had not been archived.Several data files (plaza mts files) were found without reference to the syngo.Plaza database.After the mts files were imported, the data loss was evaluated as 525 studies with 4617 series.The affected data consisted of recently acquired images and it was stored on the short-term storage (sts).These images are potentially clinically relevant for follow-up diagnosis.The user is aware of the unavailability of this data.There are no injuries attributed to this event.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; 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: 8541436
• MDR Text Key: 160869096
• Report Number: 3002808157-2019-70047
• 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: 02/18/2019

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: 02/18/2019
• Initial Date FDA Received: 04/23/2019
• 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