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

Model Number 7502029

Device Problems Use of Device Problem (1670); Loss of Data (2903); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

The incident occurred due a hardware issues with the syngo imaging xs hard drives.The amount of lost images has not yet been determined.The current system was configured as a workstation and not as a pacs.No long term storage archive was configured, thus there is no possibility to restore data from there.The affected short term storage is intended only for temporary storage of patient data until it is transferred to long term storage.The product syngo imaging xs did not contribute to the data loss, as the issue was caused by a hardware failure and the syngo imaging xs is a software solution only.No consequences have been reported, neither from this customer nor from the installed base.Customer's address: hospital (b)(6).

Event Description

It was reported that the syngo imaging xs services would not start.The station had to be rebooted, however, the same error message "network service stopped" kept being displayed on the screen.The only information that could be extracted from the logs was "e:\ drive has no enough space" and "magic view was not able to access files on it.There are no injuries attributed to this event.The incident was reported 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: 8560509
• MDR Text Key: 173458810
• Report Number: 3002808157-2017-06807
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7502029
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2017
• 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