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

Model Number 10766380, 10766382, 10766385

Device Problems Use of Device Problem (1670); Data Back-Up Problem (2902); Loss of Data (2903)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.Affected data from march 2016 onwards was analyzed and the following issues were found: issue 1: series with zero byte size images (without pixel) received by syngo imaging.Not a product issue.Issue 2: series received corrupted images with wrong transfer syntax.All received from same dicom aet.No a product issue.Issue 3: series compressed by syngo imaging which can be viewed, however they cannot be transferred to another dicom node due to additional bytes post pixel data.This may occur when mutliframe images are received without the mandatory type 1 attribute "number of frames".Root cause analysis ongoing to check if this can occur in other scenarios.Issue 4: series corrupted due to raid crash.Not a product issue.It was confirmed that issues 1,2, and 4 occurred not due to syngo product.Analysis for issue 3 is ongoing.Due to un-availability of log files and high amount of affected data, analysis takes longer time and root cause is not known at the time of writing this assessment.No consequences have been reported, neither from this customer nor from the installed base.There are no injuries attributed to the reported event.However, this issue affects diagnostic relevant data.A supplemental report will be submitted if additional information becomes available.

Event Description

During migration from the syngo imaging pacs to the syngo.Plaza pacs it was identified that 297,808 images belonging to 1,434 studies could not be transferred to the new pacs.Therefore, these images are not available in the new archive for comparison with prior studies.The affected data is dated within the time frame 2003 to 2017.There are no injuries attributed to this event.The incident occurred in (b)(6).

Manufacturer Narrative

**resubmission of initial report as per fda on 4/3/19** the investigation of the reported issue was completed with the following result.No consequences to the patient's health have been reported as a result of this incident.Data loss was assessed as low clinical relevance.The syngo imaging product did not contribute to the data loss.The potential risk of the incident was re-evaluated and assessed below reportability threshold.The data loss was observed during migration of the patient data from the syngo imaging to another pacs system.The data loss was not detected by the customer.Majority of the affected data (~97%) is more than 10 years old and clinical relevance of this data is considered low.The other portion of the affected data dated between 2016-2017 (1007 images).30 images were recovered.The remaining images had been were imported to cd and given to patients to be used for comparison for future studies.Clinical relevance of these partially unrecoverable images is also considered low.Details about the root cause.For the data from 2016-2017 : the product syngo imaging did not contribute to the data loss.For the data from 2003-2015: due to un-availability of logs files, it was not possible to find root cause of corruption of the affected data.After the migration this user site no longer uses siemens syngo imaging product for reporting purposes.Therefore, siemens cannot provide new input for analysis.However, another customer site with comparable setup was equipped with a diagnostic patch (b)(4) which provides extended logging.This site was monitored for 6 weeks with zero findings.Hence no further options to continue with root cause analysis were available.Details on data loss: findings from analysis of affected 1007 images belonging to 42 studies dated 2016 to 2017 are as following: 958 corrupted images from 11 studies received from source aet (b)(4) and stored as is.501 images resent to new study.So old images can be either deleted or ignored during migration.Remaining 457 images were not resent and reason is not known.13 images from 5 studies with pixel in icon image sequence received from (b)(4) and stored as it is.6 images from 1 study are test images and can be ignored.30 images have extra bytes appended which can be removed before migrating to plaza.However, these images can be viewed in the syngo imaging in the current form.

• Brand Name: SYNGO IMAGING
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8551848
• MDR Text Key: 161306723
• Report Number: 3002808157-2018-19877
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K082430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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: 10766380, 10766382, 10766385
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other