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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH ARTIS ZEE CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 10094137
Device Problems Use of Device Problem (1670); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2020
Event Type  malfunction  
Manufacturer Narrative
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.Internal id # (b)(4).
 
Event Description
It was reported to siemens that a 3d run aborted on the artis pheno unit.The issue happened twice with two different patients.It is unclear whether any injuries are attributed to this incident.The reported issue occurred in (b)(6).
 
Manufacturer Narrative
Siemens completed the investigation of the reported event.Unfortunately, the investigation did not reveal a clear root cause.Although the returned part has been examined and the logfile has been reviewed the root cause of the error mentioned in the complaint could not be definitively determined.According to the system specialists the most proper reason is a sporadic defect of the multi display manager (mdm) which is responsible to control the large display.This thesis is supported by the fact that the system worked well after exchanging the mdm.Finally, this investigation could not show any systematic issue or even an error burst; so, no approaches for improvements could be identified.No further measures are necessary.
 
Manufacturer Narrative
In initial report date (b)(6) 2020 was reported.Corrected data is (b)(6)2020.
 
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Brand Name
ARTIS ZEE CEILING
Type of Device
IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM  91301
MDR Report Key10191933
MDR Text Key198150665
Report Number3004977335-2020-32957
Device Sequence Number1
Product Code OWB
UDI-Device Identifier04056869010052
UDI-Public04056869010052
Combination Product (y/n)N
PMA/PMN Number
K181407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 06/24/2020
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 Number10094137
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/06/2020
Initial Date FDA Received06/24/2020
Supplement Dates Manufacturer Received06/06/2020
07/31/2020
Supplement Dates FDA Received06/24/2020
07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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