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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH SYNGO.PLAZA PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 10863173
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
The syngo. Plaza works according to specification. The reported incident occurred due to a hardware issue without contribution from the syngo. Plaza. No consequences have been reported from this customer. Internal id # (b)(4).
 
Event Description
Siemens became aware of an incident on the syngo. Plaza unit. All images in the short term storage (sts) were corrupted after a hard disk (raid) failure occurred. At the user site the syngo. Plaza system is operated in a standalone mode, i. E. Without archiving functionality. Furthermore ,customer has no other archiving solution available. None of the patient data could be recovered due to all database drives and backup drives being corrupted. Total number and time period of lost data are as follows: total number of images lost: 97868. Total number of studies corrupted: 19343. Timeline of the lost data cannot be determined as all corrupted study records have been removed from the database and the data was present only until december 6, 2019. None of the studies including the recent studies (dated between december 1 and 6, 2019) were available in the modality to resend. There was no injury associated with the issue. The reported event occurred in (b)(6).
 
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Brand NameSYNGO.PLAZA
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd.
mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key9495088
MDR Text Key220753882
Report Number3002808157-2019-11696
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10863173
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
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: 12/19/2019 Patient Sequence Number: 1
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