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

Model Number 10091637

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 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.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.Customer's address: (b)(6).

Event Description

Original issue was escalated to siemens by the customer as a simple request for service support to help determine reason why the syngo dynamics product could not receive examinations.During the investigation siemens found that the site's long term archive system had failed.Siemens service assisted the site and (b)(4) (manufacturer of the hard drive) in establishing a working archive drive.However, this site has no contract with siemens and has turned over the failed 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.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.No injury is associated with this issue.No data mix-up or loss occurred which would result in the need for a patient rescan.The reported issue 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: 8560502
• MDR Text Key: 160785181
• Report Number: 3002808157-2017-08533
• 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: 12/07/2017

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: 10091637
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• 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