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

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588)

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

Event Date 09/19/2022

Event Type  malfunction  

Event Description

Patient came for a lung biopsy procedure yesterday morning.During the procedure while the patient has already a needle in her chest, the ct 64 malfunctioned.Images were downloading slowly or would not download at all.

• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 16435482
• MDR Text Key: 310159839
• Report Number: 16435482
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23725 DA
• Patient Sex: Female