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

Model Number 10863171

Device Problems Computer Software Problem (1112); Loss of Data (2903); Data Problem (3196)

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

Event Date 12/16/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Root cause : prior to sending an acknowledgment to the outgoing modality that the image has been received, the synge.Plaza system relies on a signal from the hardware to ensure that a file is available in the sts (short term storage).A reference with a file name for the image will be added to the database.But the hardware signal "available in sts" does not ensure image being physically written to a hard disc; this signal will already be sent after availability only in the temporary cache.When a different image is received after the system is working again, the syngo.Plaza will allocate the same file name for the new image, will check that the file name does not exist in the file system and after the signal "available in sts" is received, it will add an entry to the database for the new image.Therefore, the database will end up with having two references for the same image.As long as the new image is physically available in the sts, loading and archiving for both images will be indicated as successful, although a patient data mix-up may have already occurred.This leads to the following results: - for the first received series an incorrect image is being displayed (e.G.Wrong examination parameter, wrong body part examination, wrong patient, etc).The image text in this case will not reflect correct information either.- for the later received study, the displayed image is correct, impact of the issue for the site in (b)(4): 13 images were found which could not be assigned to the correct patient , therefore they posed a risk that they will be shown inside a series to which they do not belong.For these 13 "foreign-content-images" in the image sequence inside some series it cannot be completely predicted, how they actually could contribute to a wrong diagnostic decision.In case they would be from a different body region or from a different scanner, it would be clearly obvious that they are wrong.If they are from same body region, then typically these "wrongly inserted" images would have different spatial alignment (because of even slight differing adjustment of the scanning location and parameters) and would cause a "jumping" when scrolling through the series.So user could notice.Therefore the risk is seen as rather improbable that this issue could lead to a wrong diagnosis, an injury (or even death).No harm has been reported from this site, the issue was not detected by the customer but by proactive service action.

Event Description

This issue was found during a retrospective review conducted by siemens.During the review a complaint for an issue identical to the previously reported adverse event was identified.After content of the complaint was evaluated, siemens decided to submit an adverse event report.The earlier existing mdr case was internally tracked with (b)(4), and was reported as an adverse event under report # (b)(4).The solution for the reported issue was provided by siemens in 2015.All potentially affected customers were notified about the issue via a customer safety advisory notice (update instruction sy099/14/s) reported under c&r report # 2240869-01/15/15-0002-c (z-1027-2015) in conjunction with software solution (distributed via an update instruction sy004/15/s).Additional software fixes were released via update instructions; · sy0018/15/s (c&r report 2240869-08/12/15-0025-c; z-2719-2015).· sy024/15/s ( c&r report #2240869-02/23/15-0006-c; z-1354-2015).During site checks where syngo.Plaza server crashes were observed, 13 mixed up images were detected by siemens service personnel in (b)(6) on the (b)(6), 2017.This issue turned out to be identical to the earlier case tracked with (b)(4), reported as adverse event under report # (b)(4).For the site in (b)(4) the following was determined: "image file names has been reused for different studies/series and different patients.In this site we have a series 1.2.840.113704.1.111.2224.1405102009.11, which has 13 images from different studies/series." in case of an operating system crash (bluescreen) or an unexpected crash of the syngo.Plaza dicom services, exactly during work-in-progress of storing received images, it may happen (arbitrarily, depending on the cache behavior of the operating system) that some image filenames which used last before the crash are used again for the next images received after the system resumed working.If this happens, a situation may arise when in the image table within the syngo.Plaza database two references will be pointing to the same image filename.The reference from before the crash now also points to the image written after the crash, which has content from the examination/patient after crash.These references are unidirectional, therefore no trace back from the image to the patient is possible.

• Brand Name: SYNGO PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlnagen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty boulevard; mc 65-1a; malvern 19355 ; 6104486478
• MDR Report Key: 6912109
• MDR Text Key: 89703392
• Report Number: 3002808157-2017-04283
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K093612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10863171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2017
• Date Manufacturer Received: 12/16/2014
• 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