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

Model Number 10091805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The user, who is responsible for maintaining the storage area network, chose this location for the deployment and management of multiple medical software products at the facility.The san was also used as the sole data backup location.The specific cause of the failure of the san was not shared by the customer with siemens.The syngo dynamics product has not caused or contributed to the loss of data.No further evaluation of the device is required.No further updates will be made for this reported issue.Internal id # (b)(4).

Event Description

Siemens became aware of a catastrophic loss of the customer's storage area network (san) at this site.The san is provided and maintained by the user; it is their chosen location for the deployment and management of multiple medical software products, including siemens healthcare products.The specific cause of the failure of the san was not shared by the customer with siemens.There is no indication that the deployed siemens products caused the failure of the san, either by the customer or as a technical possibility.It was subsequently determined that there were no recent data backups from which data recovery would be possible as the customer also used their san as the sole backup location.The site has an ongoing recovery effort with a 3rd party data recovery company.It has been identified that only some drives from the network have a potential for data recovery.It is not possible for siemens to determine the extent or future availability of the site's data.There was no injury associated with the issue.The loss of potentially clinically relevant data may contribute to a delay in treatment or to a path for incorrect treatment.The extent of the probability of harm occurrence for the site is incalculable as the extent of the total recovery and interim clinical operations at the concerned site is unknown to siemens.The reported event occured in (b)(6).

• Brand Name: SYNGO DYNAMICS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9175655
• MDR Text Key: 191434714
• Report Number: 3002808157-2019-01313
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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
• Date Manufacturer Received: 10/02/2019
• 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