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

Model Number 10014063

Device Problems Loss of Power (1475); Loss of Data (2903); Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Activities to repair the defective drives at the user site as well as finalization of data migration to the syngo.Plaza are on-going.The final amount of data loss (if any) can be determined only after the recovery activities at site are completed.No consequences from the user have been reported so far.

Event Description

Siemens became aware of a hardware crash of the storage drives attached to the syngo imaging product caused by power failure.Several drives hosting the syngo imaging internal database and data became inoperable.The concerned user site was in the process of transitioning its primary pacs role from the syngo imaging to the syngo.Plaza.Therefore, a synchronization of data transmission was established; however, it was planned to operate both systems in parallel until migration of all data to the syngo.Plaza was finalized.No impact on the clinical routine at the site has been observed.The user continues to read and save current examinations using the syngo.Plaza.However, in case prior images that are located on the inoperable drives are needed for a follow up reading and comparison, they would not be available.The root cause of the issue is a hardware error.The syngo imaging product did not contribute to the unavailability of images.There are no injuries related to this event.

• Brand Name: SYNGO IMAGING
• 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: 8457387
• MDR Text Key: 145247962
• Report Number: 3002808157-2019-71708
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10014063
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2019
• Date Manufacturer Received: 02/28/2019
• 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