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

Model Number 10091805

Device Problems Use of Device Problem (1670); Data Back-Up Problem (2902)

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

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.The exact cause of the loss of this historical data cannot be determined.The investigation showed that the user's it group had performed a migration of data from their old pacs to a new pacs and this is suspected to have been when the site lost their historical studies.The syngo dynamic system did not cause or contribute to the data loss as the system has no control over any sites long term archive pacs including any abilities to "protect" the studies.(b)(6).

Event Description

It was reported to siemens by a user that a simple failure to load an image study from the long term archive occurred.However, siemens identified that an unknown amount of image studies was missing in the site's long term archive.The historical study images are no longer available and considered to be unrecoverable at this point of time.However, the previous clinical study reports generated from the read of the image studies are available in the syngo dynamics for clinical comparison.There was no injury associated with this issue.No data mix-up or loss occurred which result in the need for a patient would rescan.The reported incident occurred in (b)(6).

• Brand Name: SYNGO DYNAMICS
• 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: 8560503
• MDR Text Key: 162081972
• Report Number: 3002808157-2017-86386
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102150
• 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: 06/30/2017

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: 10091805
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2017
• 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