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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT SYNGO.X WORKPLACE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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SIEMENS HEALTHCARE GMBH- AT SYNGO.X WORKPLACE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number 10281299
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens was notified of this event by fda medsun report #(b)(4). Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
 
Event Description
It was reported to siemens that a malfunction occurred while operating the syngo. X workplace on an artis zeego system. The user reported that the ct portion of the artis zeego x-ray system was not working. The or team had to turn the machine off and on three times before the machine would turn on. The user reported that this has happened over the past few days. There is no report of impact to the state of health of any patient or user involved. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameSYNGO.X WORKPLACE
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH- AT
127 henkestr.
erlangen, germany 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH- AT
henkestrasse 127
erlangen, germany 91052
GM 91052
Manufacturer Contact
meredith adams
40 liberty blvd.
malvern, PA 19355
6104486461
MDR Report Key12445503
MDR Text Key270579460
Report Number3004977335-2021-94506
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10281299
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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