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.

Manufacturer Narrative

Log data was reviewed and the results of the investigation is two-fold: (a) problem with the cable connection and connection diagrams for the interlock function, which should have stopped the table from tilting and (b) table tilting was caused by a liquid spilling onto the tilt console.It was determined from the investigation by the manufacturer that liquid spilling onto the tilt console triggered a short circuit which caused the table to tilt unexpectedly.This is being considered user error because per the caution section of the operation manual the tableside console and x-ray detectors of the support units are to be covered with sterile caps to prevent contact with liquids.This was not the case.Additionally, the table tilt movement should have been stopped by the interlock function.However the interlock function was not functioning.It was found that there was a problem with the cable connection because the connection diagram was incorrect.The cable connection and the connection diagram will be modified to correct the problem on all applicable systems.The cat-870b table has been replaced at the customer site.

• 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
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Model Number: CAT-870B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1