MAUDE Adverse Event Report: CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Use of Device Problem (1670)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 06/17/2022

Event Type  Injury  

Event Description

Unnecessarily prescribed a ct scan, then received severe over exposure to ionizing radiation.In other words i was unnecessarily exposed to high levels of ionizing radiation during a ct brain scan.Was given more than ten times the absorbed ionizing radiation dose for a brain scan and was scanned at that dose multiple times in one sitting due to a negligent ct operator and older improperly maintained and improperly calibrated ct scanner.This absorbed ionizing radiation over exposure to my brain at 15 plus msv scanned multiple times (inside ct scanner for over 10 minutes) when i only should've been scanned once, happened at the (b)(6) hospital.Fda safety report id# (b)(4).

• Brand Name: CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 15113739
• MDR Text Key: 296785333
• Report Number: MW5111147
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White