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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 Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
Resubmission of initial report due to report code error. The investigation is on-going. It has not yet been determined whether the syngo dynamics product has caused or contributed to the loss of data. No injury is associated with this issue. No data mix-up or loss occurred which would result in the need for a patient rescan. A supplemental report will be submitted if additional information becomes available.
 
Event Description
A potential loss of clinically-relevant data which may be unrecoverable was reported. The investigation into the root cause and recoverability of the data is ongoing. The clinical relevance of the potentially lost data is that the user no longer has the historical study images available if a comparison with newer images is desired, however the clinical studies and reports created from the read of the image studies are still available in the sites his. 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 Key8560709
MDR Text Key145399288
Report Number3002808157-2018-26002
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2018
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 Received06/18/2018
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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