MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS FLUOROSCOPY X RAY MACHINE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problems Energy Output Problem (1431); Unexpected Shutdown (4019)

Patient Problems Exsanguination (1841); Vascular Dissection (3160)

Event Type  Death  

Event Description

On (b)(6) 2021, my mother, (b)(6) dob (b)(6) 1948, went to (b)(6) hospital in (b)(6) for a heart catheterization.During the operation, the fluoroscopy x ray machine went down several times and was not able to be rebooted.My mother had to be moved to another room in order to use another fluoroscopy machine.When they were able to get an image, my mother's artery had been severed and she bled to death.(b)(6) was supposed to have this machine confiscated and report this death to the fda, which they admitted that they did not do.This x-ray machine is still in (b)(6) hospital and there is no telling how many more deaths have been caused because of this machine and (b)(6) criminal actions.

• Brand Name: FLUOROSCOPY X RAY MACHINE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS
• MDR Report Key: 16876127
• MDR Text Key: 314636531
• Report Number: MW5117236
• Device Sequence Number: 1
• Product Code: JAA
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White