MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	TUS-AI700/5N
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was also reported that the site has recorded this as a "near-miss incident" in their internal reporting system.Manufacturer is currently investigating into the event.
Event or Problem Description
During a pericardiocentesis procedure at (b)(6) regional medical center on (b)(6) 2021, it was reported that psi-30bx transducer started to malfunction and eventually the ultrasound system became unresponsive.The staff performed a hard shut down, resulting in the subsequent boot up to take over 4 minutes to complete.During this time, patient was still in critical stage with the needle still inserted in their chest cavity.After the bootup completed, the customer was able to continue with the procedure successfully with no patient injury occurring.
Event or Problem Description
During a pericardiocentesis procedure at phelps county regional medical center on (b)(6) 2021, it was reported that psi-30bx transducer started to malfunction and eventually the ultrasound system became unresponsive.The staff performed a hard shut down, resulting in the subsequent boot up to take over 4 minutes to complete.During this time, patient was still in critical stage with the needle still inserted in their chest cavity.After the bootup completed, the customer was able to continue with the procedure successfully with no patient injury occurring.
Additional Manufacturer Narrative
Manufacturer analyzed log files for system to conclude the following: the phenomenon is not a system lock-up but a function restriction by error processing.The error "img_135" occurs because of the rise in temperature within the transducer when leaving a transducer in the same place for an extended period of time.The equipment and transducer is functioning as intended and within specification.Manufacturer confirmed the equipment displayed an error dialog (img_135) and the customer clicked the [ok] button to close the dialog.This error occurs when there is a rise in temperature within the transducer.System log files allows for the detection of the undesirable state by properly displaying the error dialog.Based on system's log file, roughly 40 minutes after the start of use the temperature reached the upper limit of 40 degrees celsius.At the time of error occurence, the equipment displayed the error dialog and restricted some functions by error processing (to avoid low temperature burns).This is an intended reaction.The user restarted the equipment according to the error dialog and then continued to use without any further problems occurring.Log analysis confirms the equipment and transducer is functioning as intended and within specification.

• Brand Name: CANON
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimioshigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147307500
• MDR Report Key: 12569068
• Report Number: 2020563-2021-00004
• Device Sequence Number: 16513772
• Product Code: IYN
• UDI-Device Identifier: 04987670102509
• UDI-Public: (01)04987670102509
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: TUS-AI700/5N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown