MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON MEDICAL PRIME-SP10/2.000; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number PRIME-SP10/2.000

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2023

Event Type  Injury  

Event Description

I brought the patient in and had her down on the bed for an abdomen/pelvis scan without contrast.Using the foot pedal, i brought her into the scanner just above diaphragm.I then used the buttons on the scanner to raise the bed up to align her coronally.After letting go of the buttons on the scanner, the bed still proceeding to raise.I looked back at (b)(6) at the console to make sure she wasn't somehow controlling something.I then tried to correct the improper movement by using the down buttons.This action only stopped the bed from moving up, but did not allow it to move down.Each time i let off the buttons, the bed would continue to move upward into the superior portion of the gantry.I then tried using the pedals to see if i could bring the patient out of the scanner entirely.This also did not work.So i called for (b)(6) to come into the room and try moving the bed herself, with the same results.(b)(6) decided we should have the patient safely slide out of the back of the scanner while i held down the pedals to keep the bed from moving any further.We rebooted the toshiba and took the patient to the ge for her scan.(b)(6) was assisting me with catching up in ct.She was centering a patient for an abd/pelvis wo exam when she waved me in the room.If she raised her foot off the down pedal the table just kept raising.There was no way to override it.I had the patient slide down to the end of the table while (b)(6) kept her foot on the pedal.After the patient was seated on the end (b)(6) came to the back and assisted me with lowering the patient to the floor.If it would not have been caught right away by (b)(6) the patient could have been wedged between the table and the gantry.She did a great job in the situation.Toshiba has been informed also.

• Brand Name: CANON MEDICAL PRIME-SP10/2.000
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 16707196
• MDR Text Key: 313064185
• Report Number: MW5116480
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRIME-SP10/2.000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic