MAUDE Adverse Event Report: SIEMENS HEALTHCARE SIEMENS X-RAY SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number UNKNOWN

Device Problem Radiation Overexposure (3017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  Injury  

Event Description

On november 10, 2022, fujifilm healthcare americas corporation was informed of an event involving fdr d-evo g43i panel.It was reported that an exposure was taken with a high mas rate during an abdominal scan on a minor patient.One exposure was taken before the level was adjusted to the correct setting, and the imaging was completed successfully.The exposure was taken by a siemens x-ray system with the fuji d-evo panel.The total kvp and mas were 70 kvp and 74 mas.It is unclear if that exposure could lead to a safety risk.Therefore, this report is being submitted in an abundance of caution.There is no death or known serious injury associated with the event.

Manufacturer Narrative

It was confirmed that the suspect medical device involved in this event was a siemens x-ray system.Section d: suspected medical device has been updated to reflect the siemens x-ray system and not the fujifilm fdr d-evo panel.The model number, serial number, and udi number of the siemens x-ray system are unknown.Siemens was notified of this event on 12/2/2022.

Event Description

On november 10, 2022, fujifilm healthcare americas corporation was informed of an event involving siemens x-ray system.It was reported that an exposure was taken with a high mas rate during an abdominal scan on a minor patient.One exposure was taken before the level was adjusted to the correct setting, and the imaging was completed successfully.The total kvp and mas were 70 kvp and 74 mas.It is unclear if that exposure could lead to a safety risk.Therefore, this report is being submitted in an abundance of caution.There is no death or known serious injury associated with the event.

• Brand Name: SIEMENS X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE; roentgenstrasse 19-21; kemnath, bavaria 95478 ; GM 95478
• MDR Report Key: 15843138
• MDR Text Key: 304097410
• Report Number: 1000513161-2022-00020
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022,02/20/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other