MAUDE Adverse Event Report: CANON ELECTRON TUBES & DEVICES CO., LTD TOSHIBA X-RAY TUBE (MODEL UNKNOWN); ASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Diarrhea (1811); Erythema (1840); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Pain (1994); Sweating (2444); Palpitations (2467); Shaking/Tremors (2515); Ambulation Difficulties (2544); Lethargy (2560); Abdominal Distention (2601); Low White Blood Cell Count (4433); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/2020

Event Type  Injury  

Event Description

Negligent tech, (b)(6), continued imaging me 6 times despite getting unusable images and receiving "beam error" warning from x-ray machine; 4 chest and 2 abdominal.(b)(6) admitted this to (b)(6) during investigation.He further admitted that the x-ray repair company, (b)(6), was called to replace the x-ray head/tube assy.The result is the erythema over my back within 5 hours of x-ray, the 5-day diarrhea within 3 days of x-ray, swelling of abdomen, pain and weakness in back muscles, pain in hip and spine bones, weakness in arm and leg muscles, wasting of thighs and back, difficulty sitting in chair, tremors in hands, unsteady walking, heart palpitations, loss of appetite, drop in blood pressure from 120+/80 to as low as 112/54, lethargy, extreme sweating when standing.(b)(6) failed to cease using defective x-ray when problems were detected in imaging and with error message from console.Rapid deterioration in health may indicate my pending demise.(b)(6) made a flaccid attempt, only performing the inspection/investigation 3 weeks after i reported the incident.They failed to take proper actions to protect the public from harm and they failed to revoke (b)(6) license.There must be controls added to x-ray machines to prevent negligent incompetents like (b)(6) from dialing up the radiation beyond safe limits.I should have never been injured as i have been.Too early for much change in blood count.Drop in wbc from (b)(6) 2020.Fda safety report id # (b)(4).

• Brand Name: TOSHIBA X-RAY TUBE (MODEL UNKNOWN)
• Type of Device: ASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC
• Manufacturer (Section D): CANON ELECTRON TUBES & DEVICES CO., LTD
• MDR Report Key: 10919146
• MDR Text Key: 218979992
• Report Number: MW5098130
• Device Sequence Number: 1
• Product Code: ITY
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 62 YR
• Patient Weight: 112