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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); Data Problem (3196); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
Resubmission of initial report due to report code error. Siemens service and installation personnel are working with the site personnel to manually correct demographic data of the 350 patient studies. The effort is ongoing and the site is crosschecking the displayed patient demographic study information with other sources during the manual corrections. There are no reported instances of harm occurring from this issue. Per the potential complaint report, there was no injury associated with this issue. No data mix-up or loss occurred which would result in the need for a patient rescan. The syngo dynamics (or the mla) products have not caused or contributed to the crossed data. No reasonably foreseeable path to occurrence of harm can be determined.
 
Event Description
The issue occurred during a siemens-healthcare installation upgrade of the site's (b)(6) a (mla) system from sw version va20 to va30. An error occurred during the installation in the configuration between the mla and syngo dynamics (sd) products. It resulted in a crossed patient data situation for 350 patients. The patient demographic data displayed for the studies in the syngo dynamics product was affected but there was no change in the imaging modalities study patient demographics data. The error was identified and the configuration was corrected. There is no reasonably foreseeable clinical impact to the crossed data as the site is aware to cross-check the patient demographic information with other available sources while the manual corrections are taking place. The imaging modality study and patient demographic data is not affected. There are no injuries attributed to this event.
 
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Brand NameSYNGO DYNAMICS
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 Key8560711
MDR Text Key161429441
Report Number3002808157-2018-23735
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
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 Received03/28/2018
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: 04/29/2019 Patient Sequence Number: 1
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