MAUDE Adverse Event Report: X-RAY; SYSTEMS, X-RAY, MOBILE

Device Problem Use of Device Problem (1670)

Patient Problems Fatigue (1849); Muscle Weakness (1967)

Event Date 06/21/2022

Event Type  Injury  

Event Description

A 63 yo female professional administered less than 1 teaspoon of barium sulfate po.Patient felt an exceptionally high level of weakness and fatigue almost immediately.Patient c/o of concern over the high rate of serious, severe, and fatal events occurring in at risk patients.Patient refused the test.In an effort to pressure patient to get the test, the technician said she would do the test with food.Just before the test the technician switched to the barium cup, insisting it was essential.Patient to 1/2 teaspoon and immediately felt weak and fatigue.Post meal activities include rest, performing stretch exercises, walk, and other sedentary activities.The patient is on a 3rd floor pre-assessment room where patients are expect to focus on leaving the floor for a longer term floor, rehabilitation facility, home, etc.It is now 0 healthcare providers must be required to get informed consent prior to administering these tests.Fda safety report id# (b)(4).

• Brand Name: X-RAY
• Type of Device: SYSTEMS, X-RAY, MOBILE
• MDR Report Key: 14843831
• MDR Text Key: 294939691
• Report Number: MW5110557
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2022
• Patient Sequence Number: 1
• Treatment: CALCIUM THE SAME.; SIMPLE ONE-A-DAY-TYPE VITAMIN WITH CLOSE TO NO MORE THAN 100 THE RDV.
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White