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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.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 syngo dynamics system unless deleted from the system by site it policy or user actions.The syngo dynamics product has not caused or contributed to the loss of data.(b)(6).

Event Description

The issue was discovered during a simple request for service support in determining why one patient's information was not able to be called up from the archive by the syngo dynamics product.The issue was escalated by the customer in (b)(6) 2017.It was found that 155 directories (5170 objects) were missing from the site's long term archive system.There was no indication or information from the site of any policy or event which would have caused this loss.Subsequent service investigation found a closed service ticket documenting a hardware failure of the site's long term archive system (nas), which was addressed by a data recovery company in january 2017.The site's nas is not a siemen's product or responsibility.In april 2017, the site reported to siemens that the site's nas was recovered and archiving and retrieving was possible again.Though the issue is not related to the syngo dynamics product, based upon all available information, it is assumed that the data was previously lost due to a hardware failure of the site's long term archive system and this loss was not identified during the site's data recovery effort, which did not involve siemens.There are no injuries attributed to this event.The reported event 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: 8556771
• MDR Text Key: 161306123
• Report Number: 3002808157-2017-01750
• 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: 10/20/2017

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: 10090370
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 04/26/2019
• 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