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 Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.Activities are ongoing to evaluate the exact amount of affected data; however, the affected data is considered as clinically relevant.The product syngo.Plaza did not contribute to the data loss, as the issue is related to a hardware failure and the syngo.Plaza is a software solution only (b)(6).

Event Description

Per the potential complaint report, there was no injury associated with this issue.Due to an identified hardware failure in network attached storage (nas), there are missing folders containing patient images in the configured nas (nas1).A backup nas is configured, however, it is managed by a 3rd party application and not configured in the syngo.Plaza system.Contents of nas1 and nas2 are identical.Both nas systems have a large amount of empty folders for dates ranging between january 6, 2017 and april 19, 2017.The reported issue 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: 8560710
• MDR Text Key: 162081839
• Report Number: 3002808157-2018-11604
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• 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: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other