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

Model Number 10496279

Device Problems Use of Device Problem (1670); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.The analysis of the reported incidents showed no error in the syngo imaging xs.Reported data loss was not caused by the syngo imaging xs system but occurred due to the two main factors described.Additionally, the concerned site has a radiology information system (ris).A list of data, which should be available in the archive attached to the syngo imaging xs system, is maintained on the ris.First analysis of the ris status showed that in the worst case a total amount of 45746 studies may be lost due to the nas point getting corrupted.Activities are ongoing at site to reestablish lost or incorrect references between archive database and existing data container files, in order to make data accessible again for customer.After this is finished the amount of lost data will be determined.This activity will take several months.No consequences have been reported for patients.(b)(6).

Event Description

It was reported that in the course of several years the concerned customer site had experienced several incidents related to their network attached storage (nas).First reported occurrence was a hardware crash at the nas level while data migration to the nas was in progress.Second reported occurrence was an incorrect maintenance of a provisionally established set of smaller raids (redundant array of independent disks ) used instead of the crashed nas (leading to wrong file system references in the archive database).There are no injuries related to this event.This event occurred in (b)(6).

Manufacturer Narrative

Resubmission of initial report due to report code error.The investigation of the reported occurrences was completed by siemens.Syngo imaging xs system did not contribute to the data loss at the concerned site.For the first incident, it was determined that the data loss totaled to 0.02 % of all series (117 series out of 646 430 series).The lost series are dated 2013 or earlier.The customer was informed that these series are no longer available for comparison.For the second occurrence, it was identified that 23 001 studies were lost for the time period of (b)(6) 2014 - (b)(6) 2015.The customer was informed as well that these studies are not available in case they are needed for comparison reasons.Clinical relevance of the data loss was assessed as medium.

• 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
• MDR Report Key: 8556983
• MDR Text Key: 161587874
• Report Number: 3002808157-2016-53127
• 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: 08/31/2016

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10496279
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other