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

Model Number 10863171

Device Problems Computer Software Problem (1112); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.Activities are ongoing to evaluate the exact amount of affected data; however, data loss is identified for 2 studies and the data cannot be recovered as the customer site does not have an archival solution configured for the syngo.Plaza.(b)(6).

Event Description

(b)(6) 2017 customer reported that they were unable to open all images of a certain study in the syngo.Plaza viewer.The affected study contained 240 images, however, only 52 were readable.According to the syngo.Plaza's log files, the image files were written successfully to the short term storage (sts) disks, however the sts's filesystem contained only empty files (no information including dicom header is present).The syngo.Plaza system relies on windows confirmation to determine whether a file was successfully stored.Since no errors have been logged in the syngo.Plaza during the storage process to the sts and there are known intermittent hard drive issues identified in windows event logs, therefore it is assumed that the syngo.Plaza did not contribute to the corrupt sts files.There are no injuries attributed to this event.This 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: 8560504
• MDR Text Key: 161590430
• Report Number: 3002808157-2017-80231
• 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: 05/11/2017

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: 05/11/2017
• 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