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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH SYNGO DYNAMICS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
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).
 
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Brand NameSYNGO DYNAMICS
Type of DevicePICTURE 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 Key9175655
MDR Text Key191434714
Report Number3002808157-2019-01313
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K102150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
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 Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10091805
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
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

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
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