MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON CATHETERIZATION TABLE

Model Number CAT-870B

Device Problems Unintended Collision (1429); Unintended System Motion (1430); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

Table tilted uncommanded into c- arm of system causing damage to the internal workings of the table. The patient was on the table when this occurred, but was unhurt. It was reported by the customer that the table began tilting with the patient on the table without operation intervention. They were able to get the patient off the table without injury. However, the table continued to tilt into the c-arm causing irreparable damage to the table. A replacement table has been ordered. Please note that prior to the table tilting, a nurse pierced a heparin bag that was to be hung on the iv pole on the left side of the table. The bag ruptured saturating the tilt console and the foot of the table top with the heparin. The areas were cleaned, but soon after the event (table tilt) occurred. The table, table control powerboard and connecting cable are being returned to the manufacturer for investigation.

Event Description

Table tilted uncommanded into c-arm of system causing damage to the internal workings of the table. Patient was on the table, but was unhurt.

• Brand Name: CANON
• Type of Device: CATHETERIZATION TABLE
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; 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 ; 7147305000
• MDR Report Key: 8170451
• MDR Text Key: 131381504
• Report Number: 2020563-2018-00003
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CAT-870B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown