• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE GMBH SYNGO IMAGING PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 10014063
Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Loss of Data (2903)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2016
Event Type  malfunction  
Manufacturer Narrative
Resubmission of initial report due to report code error. (b)(6).
 
Event Description
It was reported that a server room at the customer's facility had a power outage in october 2016, which resulted in the failure of the raid (hard disk unit) attached to the siemens syngo imaging system. A previous power outage that occurred earlier (september 2016) had already deactivated the raid mirroring function. Therefore, the data was not protected by any back-up option. After the assessment was conducted, it was determined that 15 potentially clinically relevant studies dated between october 13th and 15th were lost. This data will not be available for diagnosis if required by physician. The syngo imaging system did not contribute to the reported data loss. No consequences have been reported from this customer. The reported event occurred in (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNGO IMAGING
Type of DevicePICTURE 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 Key8556984
MDR Text Key161306612
Report Number3002808157-2016-58408
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10014063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2016
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: 04/26/2019 Patient Sequence Number: 1
-
-