Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 INNOVA; INTERVENTIONAL FLUOROSCOPIC 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
 

GE MEDICAL SYSTEMS INNOVA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number INNOVA IGS 530
Device Problems Defective Component (2292); Improper Flow or Infusion (2954); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Event Description
The x-ray cooling failure happened on 4 separate instances over the past 2 years, with the patient on the table and not on the table.First the tube needed to be replaced and then the tube ended up having a kink in it.This disrupted the patient flow on multiple occasions.Manufacturer was contacted.They replaced fan in the tube in one instance and fixed cooling failure in another instance, resolving the issue for now.Manufacturer response for x-ray, (brand not provided) (per site reporter) manufacturer was contacted.They replaced fan in the tube in one instance and fixed cooling failure in another instance, resolving the issue for now.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INNOVA
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
GE MEDICAL SYSTEMS
3000 n. grandview blvd.
waukesha WI 53188
MDR Report Key15665596
MDR Text Key302395424
Report Number15665596
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberINNOVA IGS 530
Device Catalogue NumberINNOVA IGS 530
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2022
Event Location Hospital
Date Report to Manufacturer10/25/2022
Type of Device Usage Unknown
Patient Sequence Number1
-
-