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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; INFINIX-I
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CANON MEDICAL SYSTEMS CORPORATION CANON; INFINIX-I Back to Search Results
Model Number INFX-8000F/AH
Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/19/2020
Event Type  malfunction  
Manufacturer Narrative
To judge the need of corrective and preventative actions, if any, the manufacturer must investigate the broken console and hyper handle in detail.After receiving those parts, manufacturer will update this report.
 
Event Description
Customer alleged that during a user controlled c-arm movement with a tableside console, the hyper handle button to control direction and speed was broken.Customer alleged that the c-arm continued to move and hit the patient, against the user's intention.According to the customer, a touch sensor equipped to the c-arm was activated, and the c-arm was stopped.Customer reported that there was no harm to the patient.The accident happened between 8:00 and 8:30 am on friday (b)(6) 2020.
 
Manufacturer Narrative
After the table side console was replaced at the site, it was returned to the manufacturer for investigation.The result of the investigation is as follows.The cover of the switch was not returned because it was disposed at the site.The completion of the investigation was delayed because the switch cover, which was important for the investigation, was not returned and it took time to obtain the information necessary for the investigation regarding the returned parts.Returned parts without the cover were investigated, and manufacturer found no abnormalities.Manufacturer conducted reproduction test with using another cover of a switch.Manufacturer assumed in the test that the broken cover was squeezed and pushed the underlying switch.Manufacturer considered that the tilted switch made c-arm move without user operation before the cover came off.It was noted that this is an extremely rare case.As a result of the log investigation, manufacturer did not find any error occurrence for the device at the event time.After the incident, canon customer engineer checked all safety functions (touch sensors and emergency stop switches) and confirmed that functions were working properly.The user could stop c-arm movement using emergency stop switches.Furthermore, c-arm was slowed down around the patient by interference prevention function.These functions ensure safety in a scenario such as this case.This case is the first report of its kind to the manufacturer.Customer engineer has replaced the table side console, and the repair has been completed.Therefore, it is judged that no further corrective action is needed in this case.In regards to preventative action, the emergency stop buttom to stop movement of the c-arm support unit, as outlined in the system operation manual, will be explained again to the customer.
 
Event Description
Customer alleged that during a user controlled c-arm movement with a tableside console, the hyper handle button to control direction and speed was broken.Customer alleged that the c-arm continued to move and hit the patient, against the user's intention.According to the customer, a touch sensor equipped to the c-arm was activated, and the c-arm was stopped.Customer reported that there was no harm to the patient.The accident happened between 8:00 and 8:30 am on friday (b)(6) 2020.
 
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Brand Name
CANON
Type of Device
INFINIX-I
Manufacturer (Section D)
CANON MEDICAL SYSTEMS CORPORATION
1385 shimoishigami
otawara-shi
tochigi, 324-8 550
JA  324-8550
MDR Report Key10284143
MDR Text Key199988976
Report Number2020563-2020-00004
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/05/2020
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 NumberINFX-8000F/AH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Distributor Facility Aware Date06/22/2020
Device Age3 YR
Event Location Hospital
Initial Date Manufacturer Received 06/26/2020
Initial Date FDA Received07/16/2020
Supplement Dates Manufacturer Received06/26/2020
Supplement Dates FDA Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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