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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS AGILE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH AXIOM LUMINOS AGILE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 10502200
Device Problem Use of Device Problem (1670)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 11/06/2019
Event Type  Injury  
Manufacturer Narrative
The unit was inspected and found to be without failures.The reported issue has not reoccurred.According to the user, the footrest may have been not properly installed by personnel before use.Internal id# (b)(4).
 
Event Description
Siemens was informed by its service organization that the footrest on the luminos agile system fell off during use.System table was in the upright position; the footrest was in-place a few centimeters above the ground.The footrest dislodged from the system with a patient standing on it.The patient fell to the ground and complained of back pain following the incident.The patient was checked by local medical personnel and no injury was diagnosed.
 
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Brand Name
AXIOM LUMINOS AGILE
Type of Device
IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim 91301
GM  91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim 91301
GM   91301
Manufacturer Contact
anastasia sokolova
40 liberty blvd.
mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key9347739
MDR Text Key167176807
Report Number3004977335-2019-06297
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111292
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number10502200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received11/20/2019
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
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