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

Model Number 10496279

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.A csan (customer safety advisory notice) was released for all affected customers informing them of this problem.There have been no reports of injury to any patients.The csan sy060/12/s was reported to the fda july 18, 2012, under 2240869-07/18/12-0021-c (z-2264-2012).This issue was resolved in the syngo imaging software version va70b_113 with an update instruction sy038/13/s, which was distributed to all affected customers in march 2013.(b)(6).

Event Description

It was reported that in the syngo imaging xs there is a potential for malfunction when using the syngo imaging xs, version va70a software and higher.With va70a applications roi (region of interest) are showing incorrect values and do not match to syngo.Via and osirix.The issue is isolated to images of pixel depth greater than 12 bit (99% of all stored images).Analysis showed that this behavior is caused by a software bug.A miscalculation done for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement", and "histograms" may occur in some situations.The min/max value of pixel density in the functions "region of interest", "pixel lens", "edge enhancement", and "histograms" is not correct for images with a pixel depth greater than 12 bits.It has to be noted that the mentioned measurements shown in prior images are also not correct.All values that are calculated for images with a pixel depth less than 12 bits are correct.This incident occurred in (b)(6).

• Brand Name: SYNGO IMAGING XS
• 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: 8555849
• MDR Text Key: 161306402
• Report Number: 3002808157-2016-06106
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082430
• 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: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10496279
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2016
• 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