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U.S. Department of Health and Human Services

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

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CANON MEDICAL SYSTEMS CORPORATION CANON CATHETERIZATION TABLE Back to Search Results
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.
 
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Brand NameCANON
Type of DeviceCATHETERIZATION 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 Key8170451
MDR Text Key131381504
Report Number2020563-2018-00003
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAT-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 Received11/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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