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 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

Per the potential complaint report, there was no injury associated with this issue.No data mix-up or loss occurred which would result in the need for a patient rescan.While the syngo dynamics product cannot cause the issue found, examples of events which could have caused the loss of multiple cache directories include a raid failure, a database migration from one server to another without moving the actual cache contents, some type of database migration that populated the database with directories and files that don't actually exist, or freeing up server space in an incorrect manner.Siemens local service organization jointly with the customer it group investigated to see if any of the above activities occurred at this sit, however, the results of none documented.The syngo dynamics product did not cause or contribute to the loss of data.There are no remedial or corrective actions required from siemens healthcare.

Event Description

While evaluating a reported issue of a single instance of data load failure, siemens factory and service experts found a data loss of 1858 clinical image studies over a time period of 2012 to 2016 (entire directories missing between june 2015 and december 2016 with a few outliers missing from 2012-2014).The exact cause of the data loss could not be determined.The historical study images were not found in the permanent archive, therefore, they are considered to be unrecoverable at this point in time.The clinical relevance is that the historical images are not available for comparison with newer images however the clinical study reports generated from the read of the image studies are available.There are no injuries attributed to this event.

• 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: 8560511
• MDR Text Key: 161277744
• Report Number: 3002808157-2017-81972
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2017

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: 10091805
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 04/29/2019
• 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