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

Model Number 10014063

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

No consequences from this incident have been reported.With this information, a death or serious injury is highly improbable.

Event Description

During migration from the siemens syngo imaging to sectra pacs, it was found that 13 studies had not migrated to sectra pacs.The data loss was of clinical relevance; however, no patient rescans were required.The lost data is old and the clinical relevance of lost data is assessed by siemens experts as very low.Readings and reports for all studies have been successfully generated prior to the incident.Only one image dated 2017 is considered clinically relevant; it was corrupted due to compression after receiving.All other affected studies (9 images from 2008 and one image from 2013) are between 5-10 years old and their clinical relevance was assessed as low.There are no injuries attributed to this event.The reported event occurred in great britain.

• 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: 8532090
• MDR Text Key: 153110201
• Report Number: 3002808157-2018-56475
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• 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
• Date Manufacturer Received: 11/08/2018
• 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