• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARISTOS FX PLUS SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE GMBH AXIOM ARISTOS FX PLUS SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Model Number 10093864
Device Problem Device Fell (4014)
Patient Problem Eye Injury (1845)
Event Date 07/01/2022
Event Type  Injury  
Manufacturer Narrative
A facility contact name was not provided to siemens. Manufacturers preliminary analysis: the detailed circumstances regarding user workflow and potential technical aspects that led to the event and the cause for the issue are currently unknown. As of the date of this report, very little information could be provided by the customer facility. Access to the examination room and to the system is currently blocked by authorities. More detailed information was requested. Also, potentially replaceable parts were requested for investigation. The investigation is ongoing. Initial corrective actions/preventive actions implemented by the manufacturer: with the currently available information no general problem has been detected yet for the installed base which requires an immediate action. A supplemental report will be submitted if additional information is obtained. Internal id# (b)(4).
 
Event Description
It was reported that during an examination the axiom aristos fx plus detector fell on a patient causing a severe eye injury that necessitated surgery. The detailed circumstances regarding user workflow and potential technical aspects that led to the event and the cause for the issue are currently unknown as of the date of this report. It is not known if the patient suffered lasting eye damage. The eye injury is classified as a serious injury in this case. It is also assumed that in a similar worst-case scenario serious injury might reoccur due to the described issue. The reported event occurred in italy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAXIOM ARISTOS FX PLUS
Type of DeviceSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
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
rebecca tudor
40 liberty blvd
65-1a
malvern, PA 19355
4843234198
MDR Report Key14957406
MDR Text Key295498982
Report Number3004977335-2022-34793
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K061054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10093864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/08/2022 Patient Sequence Number: 1
-
-