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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH ARTIS Q ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 10848283
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2017017.(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 artis q zeego system.During an interventional procedure, the user reported receiving a "tube hot" error message.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
 
Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Based on an environmental issue, the temperature in the technical room was too high and therefore outside the specification.Each electrical device and medical system has a specified tolerance range in which it was tested and in which the functionality is guaranteed.Upon investigation, the customer service engineer reported that the temperature in the technical room was 38.6°c due to a failure of the customer's air conditioning system.The elevated temperature caused a rise in the system cabinet as well as an increase in the temperature of the coolant.If a coolant or temperature problem occurs during the procedure, a 30 minute countdown is displayed to the user on the monitor.This safety measure allows the user to complete a procedure in a controlled manner.According to the user manual the system can be used in a temperature range from 15 to 30°c.After the customer repaired the air conditioning system the medical system worked as specified.This kind of failure is considered a user error as the customer is responsible for the air conditioning unit.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.
 
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Brand Name
ARTIS Q ZEEGO
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forccheim, germany 91301
GM  91301
MDR Report Key8300750
MDR Text Key134851707
Report Number3004977335-2019-65588
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K141574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10848283
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/18/2019
Event Location Hospital
Date Report to Manufacturer01/18/2019
Initial Date Manufacturer Received 01/18/2019
Initial Date FDA Received02/04/2019
Supplement Dates Manufacturer Received03/21/2019
Supplement Dates FDA Received03/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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