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

Model Number 10496279

Device Problem Use of Device Problem (1670)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 7/28/20.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.This report was submitted september 27, 2016.(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 filesystem references in the archive database).There are no injuries related to this event.This event occurred in (b)(6).

• Brand Name: SYNGO IMAGING XS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS AG; 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 ; 4486478
• MDR Report Key: 6253414
• MDR Text Key: 238136741
• Report Number: 2240869-2016-53127
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2016

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: 10496279
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other