• 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 YSIO MAX STATIONARY X-RAY SYSTEM

  • 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 YSIO MAX STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 10762470
Device Problem Unintended Movement (3026)
Patient Problem Swelling/ Edema (4577)
Event Date 10/08/2021
Event Type  Injury  
Event Description
Siemens became aware of an incident that occurred on the (b)(6) max unit. A patient went in for examination and was sitting in a chair next to the patient table. While the technician was adjusting the height of the patient table, it moved down onto the patients leg. The technician then quickly pressed the emergency button to release the patient. It was reported that patient legs were pinched, and this resulted in the distal thigh of the patient being swollen. The reported incident occurred in (b)(6).
 
Manufacturer Narrative
The operator manual contains a warning not to position a patient with legs under the table and not to move the table while patient is in seated position near the table. The patient tabletop is equipped with a collision detection system that stops system movement in case a collision is detected. Only the table frame has no collision detection. The investigation is on-going. A supplemental report will be submitted if additional information becomes available. Internal id # (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameYSIO MAX
Type of DeviceSTATIONARY 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 Key12703869
MDR Text Key283822536
Report Number3004977335-2021-02110
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K181279
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10762470
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
-
-