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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSHIBA AMERICA MEDICAL SYSTEMS, INC. TOSHIBA X-RAY EQUIPMENT; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
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TOSHIBA AMERICA MEDICAL SYSTEMS, INC. TOSHIBA X-RAY EQUIPMENT; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Model Number CFI/BP/FD/C.000
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2020
Event Type  malfunction  
Event Description
Toshiba x-ray equipment not functioning properly this a.M., when equipment was started for the day.Unable to upload patient information, as well as perform any emergency x-rays.This was the same issue that occurred about 2 and half weeks ago.Biomed and toshiba notified of issues with system.Md notified of system issues and delay in start time of procedure.Patient and family notified of system issue.Toshiba representative was able to repair equipment and cases were started for the day.First scheduled cath case was delayed from 8:30am to 11:00am.Cannon rep.Replaced hardware - hard drives and reinitialized database.Device returned to service.
 
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Brand Name
TOSHIBA X-RAY EQUIPMENT
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle drive
tustin CA 92780
MDR Report Key12092204
MDR Text Key259206456
Report Number12092204
Device Sequence Number1
Product Code JAA
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 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCFI/BP/FD/C.000
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2021
Event Location Hospital
Date Report to Manufacturer06/30/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age5110 DA
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