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

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DEFINIUM 5000 X-RAY SYSTEM SOLID STATE X-RAY 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
 

GE MEDICAL SYSTEMS, LLC DEFINIUM 5000 X-RAY SYSTEM SOLID STATE X-RAY IMAGER Back to Search Results
Model Number XRA202
Device Problems Use of Device Problem (1670); Positioning Problem (3009)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 11/12/2018
Event Type  Injury  
Manufacturer Narrative
A ge healthcare investigation has been initiated and is ongoing. A follow-up mdr will be provided when ge healthcare's investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
On (b)(6) 2018, a technologist at (b)(6) reported that they were performing a standing knee patient exam with their definium 5000 fixed radiographic system. To obtain the proper knee view, the patient was positioned on a foot stool to allow proper alignment of the knees to the bucky. The patient was facing the bucky with their toes pointed to the bucky. The technologist lowered the bucky down vertically to obtain proper alignment. During the downward motion the bucky impact the patients foot. The technologist promptly raised the bucky vertically and noticed the patients foot was positioned past the edge of the foot stool and when the bucky was lowered, it impacted the patient toe. X-ray imaging showed a non-displaced fracture of the left 1st great big toe. A cast shoe was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEFINIUM 5000 X-RAY SYSTEM
Type of DeviceSOLID STATE X-RAY IMAGER
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, WI 53188
Manufacturer Contact
steven walczak
3000 north grandview boulevard
waukesha, WI 
MDR Report Key8080371
MDR Text Key127530374
Report Number2126677-2018-00018
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberXRA202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/16/2018 Patient Sequence Number: 1
-
-