MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORP. CANON BEAM LIMITING DEVICE BILPLANE X-RAY SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number BLA-900A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

Canon beam limiting device collimator allowed the top to collimate down, but not to collimate up.Fda safety report id # (b)(4).

• Brand Name: CANON BEAM LIMITING DEVICE BILPLANE X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORP.; tustin CA 92780
• MDR Report Key: 14052509
• MDR Text Key: 289022722
• Report Number: MW5108836
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2022

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
• Device Operator: Health Professional
• Device Model Number: BLA-900A
• Device Catalogue Number: BLA-900A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic