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

Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408); Audible Prompt/Feedback Problem (4020)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

Patient called with complaint about how his computed tomography (ct) procedure was administered at the hospital.During the procedure, he was not able to understand the technologist's vocal instructions through the microphone.Her voice was garbled and intermittent.He was also not able to hear all the prompts from the machine.The second prompt was not heard, "which tells you when to hold your breath for a better image capture" hence, the findings for the test came back saying, "motion artifact limits evaluation for conclusive evidence of solid pulmonary nodules." patient attributes the poor quality images to his inability to hear the prompts from the computed tomography machine, and that it affected the test results.Patient also expressed that he tried to inform the technologist that he could not hear her, and she responded back that there has never been a complaint about that and she did not believe that her speech was garbled through the microphone.

• Brand Name: COMPUTED TOMOGRAPHY MACHINE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16254201
• MDR Text Key: 308442103
• Report Number: MW5114540
• Device Sequence Number: 1
• Product Code: JAK
• 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
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male