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

Model Number 10091637

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

No evidence was found to indicate that a failure of the syngo dynamics product was responsible for the loss of historical study images from the sites long term archive.As the data is no longer available in the syngo dynamics product cache, this data is considered unrecoverable.It is not possible for siemens to further identify a root cause for this data loss.The syngo dynamics product has not caused or contributed to the loss of data.No reasonably foreseeable path to occurrence of harm can be determined.Internal id # (b)(4).

Event Description

Siemens became aware of an issue when service support request was escalated for the syngo dynamics product.The syngo dynamics product could not retrieve historical study images from the site's archive system.It was determined that 619 image studies were missing from the site's archive.The clinical relevance of the potential data loss is that the user no longer has the historical study images available if a comparison with newer images is desired, however the clinical studies and reports created from the read of the image studies will still be available in the syngo dynamics system unless deleted by the site it policy or user actions.There was no injury associated with this issue.No data mix-up or loss occurred which has any indication of resulting in the need for a patient rescan.

• Brand Name: SYNGO DYNAMICS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, pa ; 4486478
• MDR Report Key: 9732362
• MDR Text Key: 205581354
• Report Number: 3002808157-2020-18118
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10091637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• 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