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

Model Number 10090370

Device Problems Use of Device Problem (1670); Loss of Data (2903)

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

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The clinical relevance of the potentially lost data 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 sd system unless deleted from the sd system by site it policy or user action.The syngo dynamics product has not caused or contributed to the loss of data.

Event Description

Original issue was escalated as a simple request for service support in determining why the syngo dynamics product could not retrieve study images from the site's archive system.Service investigation found that the site's long term archive system (non-siemens product) had failed.The site has turned over the archive disks to a data recovery company.It is not possible for siemens to determine the extent or future availability of the site's historical data.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: 8510402
• MDR Text Key: 141799524
• Report Number: 3002808157-2018-16238
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10090370
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2018
• 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