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: TOSHIBA INFINIX ANGIOGRAPHIC MACHINE
  • 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
 

TOSHIBA INFINIX ANGIOGRAPHIC MACHINE Back to Search Results
Device Problem Data Back-Up Problem (2902)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2017
Event Type  malfunction  
Event Description
Pt had an invasive procedure - cardiac catheterization using a toshiba infinix angiographic system.The system is set to auto archive the images to a hospital based storage system, it did not.The system is set to maintain a limited number of images in its own directory prior to writing over the data, in this case the system wrote over these images before older images.The system is set in a way that new images cannot be required until the old images are archived.In this case the logs show no warning was posted.The pt later needed bypass surgery and had to undergo another invasive cardiac catheterization because the films could not be produced.Diagnosis or reason for use: unstable angina."is the product compounded: no, is the product over-the-counter: no.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFINIX ANGIOGRAPHIC MACHINE
Type of Device
INFINIX
Manufacturer (Section D)
TOSHIBA
1 marconi ste a
irvine CA 92618
MDR Report Key6816512
MDR Text Key83625560
Report NumberMW5071769
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age78 YR
Patient Weight65
-
-