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 AMERICA MEDICAL SYSTEM, INC.; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
  • 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 AMERICA MEDICAL SYSTEM, INC.; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Device Problems Failure to Power Up (1476); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2015
Event Type  malfunction  
Event Description
A toshiba ct unit went down during a study.Service was called and unit was operational.The next morning, when the machine was turned on, it was not operational.The machine would not scan and could not warm up or run phantom images.3 pts were rescheduled.Two pts were rescheduled on the day the ct unit went down during a study.Service was called but is currently unavailable due to another down unit within our system.Manufacturer response for ct scanner, (brand not provided) (per site reporter): may be problem with power supply.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
TOSHIBA AMERICA MEDICAL SYSTEM, INC.
2441 michelle dr.
tustin, CA 92780
MDR Report Key5155669
MDR Text Key28455314
Report Number5155669
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Report Date 09/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2015
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer09/30/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
-
-